Application Nr Approved Date Route Status External Links
ANDA204575 2016-06-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & 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 (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. 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.
7. Hypromelloses HYPROMELLOSES Unresolved

Active Ingredients ( 2 Total)

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