FDA.reportPublic FDA data

Application 209385

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;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
A209385-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2018-07-02
A209385-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2018-07-02
A209385-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209385-001AA
A209385-002AA
A209385-003AA

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 22:54:322026-06A209385-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-07-02a50c72e98297…
2026-08-01 22:54:322026-06A209385-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-07-02a50c72e98297…
2026-08-01 22:54:322026-06A209385-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-07-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209385-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A209385-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A209385-003AA1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209385
application number: ANDA209385
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209385
application number: ANDA209385
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy53de17b1-6d5b-c7c0-e063-6394a90a70642026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209385
application number: ANDA209385
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENElite Laboratories, Inc.27fa8190-d334-4bb9-b277-d1f44db433e32026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209385
application number: ANDA209385
ndc (product): 64850-622
ndc (product): 64850-621
ndc (product): 64850-623

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-621Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-622Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-623Oxycodone Hydrochloride and AcetaminophenOxycodone Hydrochloride and AcetaminophenElite Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76217ORIG 2023-11-03