FDA.reportPublic FDA data

Application 077727

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL5MG;200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Ibuprofen
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAmneal Pharmaceuticals of New York LLCabc33718-4e88-43ea-9ffa-2b04ffc812ef2025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Ibuprofen

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-3584Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3584Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3584Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent