Application Nr Approved Date Route Status External Links
ANDA076604 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Hydrocodone Bitartrate And Ibuprofen Tablets And Other Treatment Options Before Deciding To Use Hydrocodone Bitartrate And Ibuprofen Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (See Warnings). Hydrocodone Bitartrate And Ibuprofen Tablets Are Indicated For The Short-Term (Generally Less Than 10 Days) Management Of Acute Pain. Hydrocodone Bitartrate And Ibuprofen Tablets Are Not Indicated For The Treatment Of Such Conditions As Osteoarthritis Or Rheumatoid Arthritis.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Hydrocodone Bitartrate HYDROCODONE BITARTRATE ZINC1280665
2. Ibuprofen IBUPROFEN ZINC2647

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