Application Nr Approved Date Route Status External Links
NDA022370 2011-08-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tramadol Hydrochloride Extended-Release 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. Tramadol Hydrochloride Extended-Release Is An Opioid Agonist 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. (1)

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
2. Shellac SHELLAC Unresolved
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Povidone K30 POVIDONE K30 Unresolved
6. Starch, Corn STARCH, CORN Unresolved
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Sucrose Stearate SUCROSE STEARATE Molecular
9. Hypromelloses HYPROMELLOSES Unresolved
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE ZINC853

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