Application Information

This drug has been submitted to the FDA under the reference 020281/001.

Names and composition

"ULTRAM" is the commercial name of a drug composed of TRAMADOL HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020281/001 ULTRAM TRAMADOL HYDROCHLORIDE TABLET/ORAL 100MG
020281/002 ULTRAM TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020281/001 ULTRAM TRAMADOL HYDROCHLORIDE TABLET/ORAL 100MG
020281/002 ULTRAM TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
021692/001 ULTRAM ER TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
021692/002 ULTRAM ER TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
021692/003 ULTRAM ER TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
021693/001 RYBIX ODT TRAMADOL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING/ORAL 50MG
021745/001 RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021745/002 RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021745/003 RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
022370/001 CONZIP TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE/ORAL 100MG
022370/002 CONZIP TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE/ORAL 200MG
022370/003 CONZIP TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE/ORAL 300MG
022370/004 CONZIP TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE/ORAL 150MG
075960/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075962/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075963/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075964/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075968/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075974/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075977/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075980/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075981/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075982/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075983/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
075986/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
076003/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
076100/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
078783/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
078783/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
078783/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
078935/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
090404/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
091498/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
091607/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
091607/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
091607/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
091609/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
091609/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
091609/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
200491/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
200491/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
200491/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
200503/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
200503/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
200503/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
201384/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
201384/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
201384/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
201973/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
202075/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
202390/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
203494/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG
204421/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
204421/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
204421/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
205257/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 100MG
205257/002 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 200MG
205257/003 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE/ORAL 300MG
205702/001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET/ORAL 50MG

Ask a doctor

A licensed doctor will try to answer your question for free as quickly as possible. Free of charge during the beta period.

Answered questions

I AM TAKING ULTRAM ER 100 MG TABLET ORT WHAT ARE THOSE PILLS FOR?
I AM TAKING ULTRAM ER 100MG TABLETS AT NIGHT. I TAKE THEM AT BEDTIME AND IT'S THREE AND FOUR HOURS LATER AND I AM STILL UP ARE THESE PILLS TO SLEEP OR FOR PAIN ? BECAUSE I HAVE PAIN ALL NIGHT LONG. NEXT DAY I AM DIZZY ALL MORNING Asked by Shayne Azebedo 1 year ago.

INDICATIONS ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. DOSAGE AND ADMINISTRATION ULTRAM ER should not be used in patients with: * creatinine clearance less than 30 mL/min, * severe hepatic impairment (Child-Pugh Class C) (See WARNINGS, Use in Renal and Hepatic Disease). ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and Drug, Abuse And Addiction). Adults (18 years of age and over) ULTRAM ER should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. ULTRAM ER should not be administered at a dose exceeding 300 mg per day. Individualization of Dose Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of ULTRAM ER have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg. In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. ULTRAM ER should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population. ULTRAM ER was administered to a total of 3108 patients during studies conducted in the U.S. These included four double-blind studies in patients with osteoarthritis and/or chronic low back pain and one open-label study in patients with chronic non-malignant pain. A total of 901 patients were 65 years or older. Adverse events increased with dose from 100 mg to 400 mg in the two pooled, twelve-week, randomized, double-blind, placebo-controlled studies in patients with chronic non-malignant pain.(see Table 2). Answered by Emilia Schiraldi 1 year ago.

Ultram is used to treat moderate to severe pain. Answered by Robt Raisbeck 1 year ago.


What is the dosage of Ultram?
Asked by Shantae Leight 1 year ago.

Ultram also known as the generic Tramadol. The standard dose is 50 mg. On my prescription it is 4 times a day or as needed. I have been on this for years. I don't remember taking it any more then twice a day. I try to use prescription ibuprophen (600mg) first before I use Ultram. The Ibuprophen is great at reducing inflammation. My friend was taking Ultram 50mg four times a day for a sprained neck. When she was no longer in pain, she stopped taking it. To her surprise and shock, she started to have withdrawal symptoms similiar to narcotic withdrawal. Ultram, although not a narcotic---works on the same brain receptors. It was the first time I heard that it could cause a tolerance and withdrawal. Answered by Dovie Plante 1 year ago.

take Ultram 100 mg after every 4-7 hours daily. You can buy 100 mg online from yourmeds247 Answered by Bradford Vinal 1 year ago.

Ultram/Tramadol one to two tablets every six hours. 50mg. I've been taking this stuff for a week now, and I have to say it's bunk, it's crap, and it does nothing. Answered by Alexandra Mcquigg 1 year ago.

Usually 50 mg is the standard prescribed dose. Answered by Lizzette Jarboe 1 year ago.

i believe the correct dosage is 5mg or 10mg if you have access to a PDR use it if not WEB MD is great Answered by Ava Quiel 1 year ago.


Is Ultram (Tramadol) Addictive?
Is Ultram (tramadol) addictive? Thank You. Asked by Alise Swatman 1 year ago.

Ultram is labeled a non-narcotic pain medication; however it has the same effects on the brain that narcotics do....so it IS addictive. I became extremely addicted to Ultram (although I was taking it as prescribed) and it was horrible withdrawing from it. Many doctors are handing out Ultram/Tramadol/Ultracet b/c it is listed as a non-narcotic and they don't realize the danger of the addictive potential. If you google 'Tramadol addiction', you will find all kinds of information about it's addiction potential...and you'll read a lot of terrible stories about it. Good luck to you. Answered by Deidra Largo 1 year ago.

Here is a link for peoples experiences, good and bad Answered by Leon Rohrbacher 1 year ago.


What is the side effects of ultram?
i'm taking medication; ultram i need to know the side effects. Asked by Tiny Stolinski 1 year ago.

Ultram side effects: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ultram and call your doctor at once if you have any of these serious side effects: * seizure (convulsions); a red, blistering, peeling skin rash; or shallow breathing, weak pulse. Continue taking Ultram and talk to your doctor if you have any of these less serious side effects: * dizziness, drowsiness, weakness; nausea, vomiting, constipation, loss of appetite;blurred vision; flushing (redness, warmth, or tingly feeling); or sleep problems (insomnia). Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. Answered by Jone Wikert 1 year ago.

log on the internet,go to health,and type in ultram.you need to why you are taking this for.hope you find what your looking Answered by Pasty Weinrib 1 year ago.

feeling hot and sweating Answered by Malik Lepretre 1 year ago.


I AM TAKING ULTRAM ER 100 MG TABLET ORT WHAT ARE THOSE PILLS FOR?
I AM TAKING ULTRAM ER 100MG TABLETS AT NIGHT. I TAKE THEM AT BEDTIME AND IT'S THREE AND FOUR HOURS LATER AND I AM STILL UP ARE THESE PILLS TO SLEEP OR FOR PAIN ? BECAUSE I HAVE PAIN ALL NIGHT LONG. NEXT DAY I AM DIZZY ALL MORNING Asked by Alonzo Auyon 1 year ago.

INDICATIONS ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. DOSAGE AND ADMINISTRATION ULTRAM ER should not be used in patients with: * creatinine clearance less than 30 mL/min, * severe hepatic impairment (Child-Pugh Class C) (See WARNINGS, Use in Renal and Hepatic Disease). ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and Drug, Abuse And Addiction). Adults (18 years of age and over) ULTRAM ER should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. ULTRAM ER should not be administered at a dose exceeding 300 mg per day. Individualization of Dose Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of ULTRAM ER have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg. In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. ULTRAM ER should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population. ULTRAM ER was administered to a total of 3108 patients during studies conducted in the U.S. These included four double-blind studies in patients with osteoarthritis and/or chronic low back pain and one open-label study in patients with chronic non-malignant pain. A total of 901 patients were 65 years or older. Adverse events increased with dose from 100 mg to 400 mg in the two pooled, twelve-week, randomized, double-blind, placebo-controlled studies in patients with chronic non-malignant pain.(see Table 2). Answered by Sachiko Spinka 1 year ago.

Ultram is used to treat moderate to severe pain. Answered by Darlena Bomaster 1 year ago.


What is the dosage of Ultram?
Asked by Devorah Chauarria 1 year ago.

Ultram also known as the generic Tramadol. The standard dose is 50 mg. On my prescription it is 4 times a day or as needed. I have been on this for years. I don't remember taking it any more then twice a day. I try to use prescription ibuprophen (600mg) first before I use Ultram. The Ibuprophen is great at reducing inflammation. My friend was taking Ultram 50mg four times a day for a sprained neck. When she was no longer in pain, she stopped taking it. To her surprise and shock, she started to have withdrawal symptoms similiar to narcotic withdrawal. Ultram, although not a narcotic---works on the same brain receptors. It was the first time I heard that it could cause a tolerance and withdrawal. Answered by Tatyana Mascolo 1 year ago.

take Ultram 100 mg after every 4-7 hours daily. You can buy 100 mg online from yourmeds247 Answered by Jovan River 1 year ago.

Ultram/Tramadol one to two tablets every six hours. 50mg. I've been taking this stuff for a week now, and I have to say it's bunk, it's crap, and it does nothing. Answered by Edmundo Pasion 1 year ago.

Usually 50 mg is the standard prescribed dose. Answered by Carroll Burnie 1 year ago.

i believe the correct dosage is 5mg or 10mg if you have access to a PDR use it if not WEB MD is great Answered by Norah Vitro 1 year ago.


Is Ultram (Tramadol) Addictive?
Is Ultram (tramadol) addictive? Thank You. Asked by Leeanne Winingear 1 year ago.

Ultram is labeled a non-narcotic pain medication; however it has the same effects on the brain that narcotics do....so it IS addictive. I became extremely addicted to Ultram (although I was taking it as prescribed) and it was horrible withdrawing from it. Many doctors are handing out Ultram/Tramadol/Ultracet b/c it is listed as a non-narcotic and they don't realize the danger of the addictive potential. If you google 'Tramadol addiction', you will find all kinds of information about it's addiction potential...and you'll read a lot of terrible stories about it. Good luck to you. Answered by Elliot Stubler 1 year ago.

Here is a link for peoples experiences, good and bad Answered by Keesha Attebery 1 year ago.


What is the side effects of ultram?
i'm taking medication; ultram i need to know the side effects. Asked by Margurite Fugah 1 year ago.

Ultram side effects: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ultram and call your doctor at once if you have any of these serious side effects: * seizure (convulsions); a red, blistering, peeling skin rash; or shallow breathing, weak pulse. Continue taking Ultram and talk to your doctor if you have any of these less serious side effects: * dizziness, drowsiness, weakness; nausea, vomiting, constipation, loss of appetite;blurred vision; flushing (redness, warmth, or tingly feeling); or sleep problems (insomnia). Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. Answered by Lizette Lougheed 1 year ago.

log on the internet,go to health,and type in ultram.you need to why you are taking this for.hope you find what your looking Answered by Jerica Lozano 1 year ago.

feeling hot and sweating Answered by Whitley Franceski 1 year ago.


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