oxycodone and acetaminophen

Product NDC
57664-160
11-digit product format
576640160
Labeler code
57664
Product ID
57664-160_8df48502-9503-4e53-b637-23f035271bf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090535
Marketing category
ANDA
Marketing start
2015-11-02
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct57664-160DDiscontinued by firm2026-10-05
excluded packagepackage57664-16057664-160-88DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage57664-160-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-160-88f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-160-882ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-160-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-160-88cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-160-88cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-160-88302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-160-88ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-160-880efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-160-88ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-160-88367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-160-88557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090535-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORAL2013-12-26
A090535-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORAL2013-12-26
A090535-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORAL2013-12-26
A090535-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORAL2013-12-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-2684e616aacf4f…
2026-09-14 22:38:342026-08A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-2684e616aacf4f…
2026-09-14 22:38:342026-08A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-2684e616aacf4f…
2026-09-14 22:38:342026-08A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-2684e616aacf4f…
2026-08-18 06:07:402026-07A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090535-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORAL2013-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090535-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2013-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090535-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2013-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090535-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2013-12-265bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090535-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090535-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090535-003AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090535-004AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090535-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090535-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090535-003AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090535-004AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090535-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090535-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090535-003AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090535-004AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090535-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090535-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090535-003AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090535-004AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090535-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090535-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090535-003AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090535-004AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090535-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090535-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090535-003AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090535-004AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090535-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090535-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090535-003AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090535-004AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090535-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090535-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090535-003AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090535-004AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090535-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090535-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090535-003AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090535-004AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090535-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090535-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090535-003AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090535-004AA1c0c555d07b60…

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
57664-160-882020-09-14C16284748780-1ab0e2407-2e17-f274-e053-dbdaa90a6471Oxycodone and Acetaminophen Tablets, USP CII
57664-160-882020-07-22C16284748780-1ab0e2407-2e17-f274-e053-dbdaa90a6471Oxycodone and Acetaminophen Tablets, USP CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-160-88EA - Each57664-16098ffb2bb-8590-42b2-82e2-3cfa95fd5c9d12016-07-19

DailyMed Socrata Ingredients#