FDA.reportPublic FDA data

Application 203863

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

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
A203863-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2018-03-30
A203863-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2018-03-30
A203863-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2018-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203863-001AA
A203863-002AA
A203863-003AA

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 22:54:322026-06A203863-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-03-30a50c72e98297…
2026-08-01 22:54:322026-06A203863-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-03-30a50c72e98297…
2026-08-01 22:54:322026-06A203863-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203863-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A203863-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A203863-003AA1a50c72e98297…

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 AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEpic Pharma, LLC5179d4ab-6d57-4613-84fc-de3f6edd6a532025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203863
application number: ANDA203863
ndc (product): 42806-112
ndc (product): 42806-113
ndc (product): 42806-111

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
42806-111Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEpic Pharma, LLCANDACurrent
42806-112Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEpic Pharma, LLCANDACurrent
42806-113Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEpic Pharma, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76338ORIG 2023-11-03