FDA.reportPublic FDA data

Application 209924

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;2.5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
004HYDROCODONE 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;2.5MGTABLET / ORALAA2018-11-16
A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2018-11-16
A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2018-11-16
A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2018-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209924-001AA
A209924-002AA
A209924-003AA
A209924-004AA

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 22:54:322026-06A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16a50c72e98297…
2026-08-01 22:54:322026-06A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16a50c72e98297…
2026-08-01 22:54:322026-06A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16a50c72e98297…
2026-08-01 22:54:322026-06A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209924-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A209924-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A209924-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A209924-004AA1a50c72e98297…

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 ACETAMINOPHENElite Laboratories, Inc.89b8145f-5310-4b58-a65d-586dc90d642d2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209924
application number: ANDA209924
ndc (product): 64850-631
ndc (product): 64850-632
ndc (product): 64850-630
ndc (product): 64850-633

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76429ORIG 2023-11-07