FDA.reportPublic FDA data

Application 076023

Type
ANDA
Sponsor
TEVA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076023-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORAL2003-04-11

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A076023-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2003-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076023-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2003-04-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076023-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2003-04-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076023-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORAL2003-04-11a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.