Oxycodone and Acetaminophen

Product NDC
67296-1401
Requested package NDC
67296-1401-8
11-digit product format
672961401
Labeler code
67296
Product ID
67296-1401_9c9fa3e2-20d5-7794-e053-2a95a90a4727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, 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
2021-12-31
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 packagepackage67296-140167296-1401-8IInactivated by FDA2026-08-03

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 · 19 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 2025-12-05IInactivated by FDAd630ba8d3edf…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 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
377068df-225f-7318-a910-a1987cdfa361Product name320170608
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1401-1Oxycodone and Acetaminophen10 in 1 BOTTLETABLET103
67296-1401-6Oxycodone and Acetaminophen6 in 1 BOTTLETABLET63
67296-1401-8Oxycodone and Acetaminophen12 in 1 BOTTLETABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1401OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 3 package rows20200122_50d3a17f-34ed-219f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN50d3a17f-34ed-219f-e054-00144ff88e883
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD50d3a17f-34ed-219f-e054-00144ff88e883
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY50d3a17f-34ed-219f-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1401-86729614010812 TABLET in 1 BOTTLE (67296-1401-8) 12 tablet2008-12-160000-00-00NoNoCurrent