OXYCODONE AND ACETAMINOPHEN

Product NDC
63629-3770
11-digit product format
636293770
Labeler code
63629
Product ID
63629-3770_719aa19b-24b8-9a20-a00e-f6335ecd4b53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040550
Marketing category
ANDA
Marketing start
2009-04-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3770DDiscontinued by firm2026-08-17
excluded packagepackage63629-377063629-3770-1DDiscontinued by firm2026-08-17
excluded packagepackage63629-377063629-3770-2DDiscontinued by firm2026-08-17
excluded packagepackage63629-377063629-3770-3DDiscontinued by firm2026-08-17
excluded packagepackage63629-377063629-3770-4DDiscontinued by firm2026-08-17
excluded packagepackage63629-377063629-3770-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 90 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3770-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3770-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3770-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3770-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3770-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3770-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3770-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3770-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3770-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3770-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3770-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3770-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3770-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3770-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3770-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3770-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3770-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3770-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3770-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3770-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3770-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3770-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3770-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3770-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3770-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3770-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3770-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3770-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3770-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3770-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3770-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3770-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3770-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3770-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3770-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3770-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3770-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3770-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3770-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3770-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3770-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3770-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3770-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3770-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3770-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3770-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3770-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3770-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3770-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3770-3ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040550-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE500MG;7.5MGTABLET / ORAL2004-06-30
A040550-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE650MG;10MGTABLET / ORAL2004-06-30

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040550-001OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2004-06-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040550-002OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2004-06-30bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3770-1EA - Each63629-37702660259f-fbb9-483c-97e1-f4636affcc3512012-07-24
63629-3770-2EA - Each63629-37702c305bc5-6235-4831-930d-797bcae0189512012-07-24
63629-3770-3EA - Each63629-37701bcd8103-bcf6-4959-9ad8-85c48d1733ee12012-07-24
63629-3770-4EA - Each63629-3770c84a2fa0-0ab7-4cc3-8d75-221af39c100712012-07-24
63629-3770-5EA - Each63629-37701f8863da-fd65-467a-9379-9021915643e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]1