Oxycodone and Acetaminophen

Product NDC
68308-475
11-digit product format
683080475
Labeler code
68308
Product ID
68308-475_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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68308-475DDiscontinued by firm2026-10-15
excluded packagepackage68308-47568308-475-47DDiscontinued by firm2026-10-15

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68308-475-47DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68308-475-47IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68308-475-47IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68308-475-47IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68308-475-47IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68308-475-47IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68308-475-47UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68308-475-47UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68308-475-47UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-20c2088c7a36db…
2026-10-15 13:18:302026-09A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-20c2088c7a36db…
2026-10-15 13:18:302026-09A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-20c2088c7a36db…
2026-10-15 13:18:302026-09A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-20c2088c7a36db…
2026-10-15 13:18:302026-09A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-20c2088c7a36db…
2026-10-15 13:18:302026-09A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-20c2088c7a36db…
2026-09-14 22:38:342026-08A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-2084e616aacf4f…
2026-08-18 06:07:402026-07A090177-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090177-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090177-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090177-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090177-005OXYCODONE AND ACETAMINOPHEN500MG;7.5MGTABLET / ORAL2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A090177-006OXYCODONE AND ACETAMINOPHEN650MG;10MGTABLET / ORAL2008-10-20caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A090177-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A090177-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A090177-003AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A090177-004AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090177-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090177-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090177-003AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090177-004AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090177-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090177-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090177-003AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090177-004AA1ea99ee380514…
2023-05-13 08:27 UTC2023-05A090177-001AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A090177-002AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A090177-003AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A090177-004AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090177-001AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090177-002AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090177-003AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090177-004AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090177-001AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090177-002AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090177-003AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090177-004AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090177-001AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090177-002AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090177-003AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090177-004AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090177-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A090177-002AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A090177-003AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A090177-004AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090177-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090177-002AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090177-003AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090177-004AA1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68308-475-472025-09-08C16284748780-12cef2736-9898-d83d-e063-dadaa90ab31fOxycodone and Acetaminophen Tablets, USP CII
68308-475-472025-01-30C16284748780-12cef2736-9898-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
68308-475-47EA - Each68308-475e9790259-63a3-4762-aa2c-c9b203d625dc12013-05-02

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
68308-475OXYCODONE 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
68308-475-476830804754710 BLISTER PACK in 1 CARTON (68308-475-47) > 10 TABLET in 1 BLISTER PACK10 blister pack2008-12-160000-00-00NoNoCurrent