FDA.reportPublic FDA data

Application 204575

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

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 1.

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
A204575-001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204575-001AB

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 22:54:322026-06A204575-001HYDROCODONE BITARTRATE AND IBUPROFEN7.5MG;200MGTABLET / ORALAB2016-06-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204575-001AB1a50c72e98297…

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 · 1 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 reactionsExact identifier
application applno (ANDA): 204575
application number: ANDA204575
ndc (product): 13107-004

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
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
13107-004Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAurolife Pharma, LLCANDACurrent
67296-1655Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1655Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76044ORIG 2023-11-02