FDA.reportPublic FDA data

Application 077723

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL7.5MG;200MGNoNo
002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL10MG;200MGNoNo
003HYDROCODONEHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL5MG;200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077723-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-06
A077723-002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06
A077723-003HYDROCODONEHYDROCODONE BITARTRATE; IBUPROFEN5MG;200MGTABLET / ORAL2006-11-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077723-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2006-11-06a50c72e98297…
2026-08-01 22:54:322026-06A077723-002HYDROCODONE BITARTRATE AND IBUPROFEN10MG;200MGTABLET / ORAL2006-11-06a50c72e98297…
2026-08-01 22:54:322026-06A077723-003HYDROCODONE5MG;200MGTABLET / ORAL2006-11-06a50c72e98297…

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar Pharmaceutical, Inc.ANDACurrent
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3586Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
0603-3897Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenPar PharmaceuticalANDACurrent
50991-579IBUDONEhydrocodone bitartrate and ibuprofenPoly PharmaceuticalsANDACurrent
55700-639Hydrocodone Bitartrate and Ibuprofenhydrocodone bitartrate and ibuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-296HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76162ORIG 2023-11-03