FDA.reportPublic FDA data

Application 087406

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo

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
A087406-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALApproved before 1982

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087406-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALApproved before 1982cb3db0bc1861…

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxycodone and acetaminophenOXYCODONE AND ACETAMINOPHENFH2 Pharma LLC88d97caf-bcf5-3cde-e053-2995a90acf4a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENMajor Pharmaceuticals1d52272f-a607-4002-a61c-341964522b822026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackac6b4a26-7ead-458e-8a3d-591aa07093432026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack25c03c47-0057-41b6-a530-c6ea85eb750f2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackef2c1fe2-75dd-43cf-871d-540c5e36d3632026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackfcb09a57-76d8-413c-801b-8d8ea0c3f1db2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack1c793d37-cbc9-4d76-a84a-d076b51011432026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd1cb17-4aea-a750-e063-6394a90a95942026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd2e535-dd11-4bfb-e063-6394a90a9fbc2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENEywa Pharma Inc1da85ac1-46a2-4081-b533-4890ec9e04822026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cf4c474-556e-5ebf-e063-6394a90acaf02026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4d9e7c39-3e71-48c7-87c7-302db1835f112026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepacke6c47385-638a-41cd-93d9-b7ee205aa0942026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRhodes Pharmaceuticals LLC5999f3c3-3225-4d24-82cd-0b8d7a3095872026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.f9cf218c-af5e-4249-aa3b-a8555ed022782026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack639aba0b-1ef6-415f-9732-ebf52bcc1b862026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3339d3bd-b416-4c5b-8984-0c376544d8a92026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE AND ACETAMINOPHEN
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAvPAK7055acd5-1cbb-397e-e053-2a91aa0a38522026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone and Acetaminophen