Application Nr Approved Date Route Status External Links
ANDA076642 2007-10-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hydrocodone Bitartrate And Ibuprofen Tablets Are Indicated For The Short-Term (generally Less Than 10 Days) Management Of Acute Pain. Hydrocodone Bitartrate And Ibuprofen Are Not Indicated For The Treatment Of Such Conditions As Ostearthritis Or Rheumatoid Arthritis.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 2 Total)

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