FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
68308-480
Requested package NDC
68308-480-47
11-digit product format
683080480
Labeler code
68308
Product ID
68308-480_151b3ec5-d0f2-446d-9db9-c9e5238fb5ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA090177
Marketing category
ANDA
Marketing start
2008-12-16
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68308-48068308-480-47DDiscontinued by firm2026-08-03

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 1 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090177-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORAL2008-10-20
A090177-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORAL2008-10-20
A090177-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORAL2008-10-20
A090177-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORAL2008-10-20
A090177-005OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE500MG;7.5MGTABLET / ORAL2008-10-20
A090177-006OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE650MG;10MGTABLET / ORAL2008-10-20

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-202680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090177-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090177-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090177-003AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090177-004AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090177-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090177-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090177-003AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090177-004AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090177-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090177-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090177-003AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090177-004AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090177-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090177-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090177-003AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090177-004AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090177-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090177-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090177-003AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090177-004AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090177-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090177-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090177-003AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090177-004AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090177-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090177-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090177-003AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090177-004AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090177-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090177-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090177-003AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090177-004AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090177-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090177-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090177-003AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090177-004AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090177-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090177-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090177-003AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090177-004AA1c0c555d07b60…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68308-480-472025-09-08C16284748780-12cef2736-9898-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen Tablets, USP CII
68308-480-472025-01-30C16284748780-12cef2736-9898-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen Tablets, USP CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-480-47EA - Each68308-480a62cb7af-454a-4663-b907-afb2ef2f933612013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
Oxycodone HydrochlorideACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
AcetaminophenACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
OxycodoneACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
crospovidoneINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-480OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [MAYNE PHARMA INC.]14Legacy NDC20221223_205be197-5ad5-4849-bc78-5fda9927b531.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68308-480-476830804804710 BLISTER PACK in 1 CARTON (68308-480-47) > 10 TABLET in 1 BLISTER PACK10 blister pack2008-12-160000-00-00NoNoCurrent