FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
67296-1392
Requested package NDC
67296-1392-1
11-digit product format
672961392
Labeler code
67296
Product ID
67296-1392_d61b7f4e-02d4-7dcf-e053-2995a90a41c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA201972
Marketing category
ANDA
Marketing start
2016-12-01
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-139267296-1392-1IInactivated by FDA2026-08-03

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

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
A201972-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;2.5MGTABLET / ORALAA2013-07-15
A201972-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;5MGTABLET / ORALAA2013-07-15
A201972-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;7.5MGTABLET / ORALAA2013-07-15
A201972-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE325MG;10MGTABLET / ORALAA2013-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A201972-001AA
A201972-002AA
A201972-003AA
A201972-004AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15a50c72e98297…
2026-08-01 22:54:322026-06A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15a50c72e98297…
2026-08-01 22:54:322026-06A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15a50c72e98297…
2026-08-01 22:54:322026-06A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201972-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A201972-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A201972-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A201972-004AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAurolife Pharma, LLC69df20d9-b1d5-47dc-9ff0-29987284f8c72025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackc12c26be-ba05-4d25-a2bf-f87623c6ae572024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdd4dbe5b-8d07-4a96-a78d-2f20da761dad2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdf97ea5a-51df-453b-b1b4-edc74c718ee72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201972
application number: ANDA201972

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1392-02026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-12026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-22026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-32026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-42026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-52026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-62026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-72026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-82026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-92026-01-29C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-02024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-12024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-22024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-32024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-42024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-52024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-62024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-72024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-82024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-92024-08-07C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-02024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-12024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-22024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-32024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-42024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-52024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-62024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-72024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-82024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325
67296-1392-92024-01-30C16284748780-11030e365-4765-111a-e063-dadaa90a10e2Oxy/Apap 5/325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1392-0Oxycodone and Acetaminophen40 in 1 BOTTLETABLET405
67296-1392-1Oxycodone and Acetaminophen10 in 1 BOTTLETABLET105
67296-1392-2Oxycodone and Acetaminophen20 in 1 BOTTLETABLET205
67296-1392-3Oxycodone and Acetaminophen30 in 1 BOTTLETABLET305
67296-1392-4Oxycodone and Acetaminophen12 in 1 BOTTLETABLET125
67296-1392-5Oxycodone and Acetaminophen50 in 1 BOTTLETABLET505
67296-1392-6Oxycodone and Acetaminophen6 in 1 BOTTLETABLET65
67296-1392-7Oxycodone and Acetaminophen15 in 1 BOTTLETABLET155
67296-1392-8Oxycodone and Acetaminophen60 in 1 BOTTLETABLET605
67296-1392-9Oxycodone and Acetaminophen4 in 1 BOTTLETABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1392OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]5Legacy NDC, 10 package rows20240808_50732645-a9ea-3bef-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN50732645-a9ea-3bef-e054-00144ff8d46c5
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD50732645-a9ea-3bef-e054-00144ff8d46c5
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY50732645-a9ea-3bef-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1392-16729613920110 TABLET in 1 BOTTLE (67296-1392-1) 10 tablet2016-12-010000-00-00NoNoCurrent