Oxycodone and Acetaminophen

Product NDC
63629-8879
11-digit product format
636298879
Labeler code
63629
Product ID
63629-8879_9fb7986f-172b-4e3a-a61d-94cca7b8b9ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201278
Marketing category
ANDA
Marketing start
2014-08-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8879DDiscontinued by firm2026-08-10
excluded packagepackage63629-887963629-8879-1DDiscontinued by firm2026-08-10
excluded packagepackage63629-887963629-8879-2DDiscontinued by firm2026-08-10
excluded packagepackage63629-887963629-8879-3DDiscontinued by firm2026-08-10

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
A201278-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2014-08-28
A201278-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2014-08-28
A201278-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2014-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201278-001AA
A201278-002AA
A201278-003AA

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-002OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2014-08-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-003OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2014-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201278-001OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2014-08-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201278-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201278-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201278-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201278-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201278-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201278-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201278-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201278-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201278-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201278-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201278-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201278-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201278-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201278-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201278-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201278-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201278-001AA18072bd15b7f6…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8879OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]103Legacy NDC20240602_626b7834-edb8-4d13-af5c-fff97d4eb9de.zip

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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackac6b4a26-7ead-458e-8a3d-591aa07093432026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackef2c1fe2-75dd-43cf-871d-540c5e36d3632026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackfcb09a57-76d8-413c-801b-8d8ea0c3f1db2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack1c793d37-cbc9-4d76-a84a-d076b51011432026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3cd2e535-dd11-4bfb-e063-6394a90a9fbc2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4d9e7c39-3e71-48c7-87c7-302db1835f112026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepacke6c47385-638a-41cd-93d9-b7ee205aa0942026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRhodes Pharmaceuticals LLC5999f3c3-3225-4d24-82cd-0b8d7a3095872026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack639aba0b-1ef6-415f-9732-ebf52bcc1b862026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone/APAPOXYCODONE/APAPDirect_Rxe84245ca-957f-e85b-e053-2a95a90a836b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENRedPharm Drug2c6014de-8901-9d83-e063-6294a90ad37b2025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
PercocetOXYCODONE/APAPDirect_Rxee151649-b52a-0a51-e053-2a95a90a6c352025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPad03068c-1af4-46ce-bdea-c2745b1c1e522022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.3e89f02d-b6e7-4641-82d4-f756518a89142022-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.0dcb491a-54e8-486b-9575-788525a178cf2021-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201278
application number: ANDA201278

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8879-16362988790130 TABLET in 1 BOTTLE, PLASTIC (63629-8879-1) 30 tablet2021-10-040000-00-00NoNoCurrent
63629-8879-26362988790290 TABLET in 1 BOTTLE, PLASTIC (63629-8879-2) 90 tablet2021-10-040000-00-00NoNoCurrent
63629-8879-36362988790360 TABLET in 1 BOTTLE, PLASTIC (63629-8879-3) 60 tablet2021-10-040000-00-00NoNoCurrent