FDA.reportPublic FDA data

Oxycodone and Acetaminophen

Product NDC
67296-1392
Requested package NDC
67296-1392-7
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#

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 packagepackage67296-139267296-1392-7IInactivated 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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201972-001OXYCODONE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-002OXYCODONE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-003OXYCODONE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-004OXYCODONE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-07-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201972-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201972-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201972-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201972-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201972-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201972-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201972-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201972-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201972-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201972-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201972-004AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201972-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-003AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201972-004AA1d06236e962d9…

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, Related label table
NDCEffectiveRelated label
67296-1392-02026-01-29Oxy/Apap 5/325
67296-1392-12026-01-29Oxy/Apap 5/325
67296-1392-22026-01-29Oxy/Apap 5/325
67296-1392-32026-01-29Oxy/Apap 5/325
67296-1392-42026-01-29Oxy/Apap 5/325
67296-1392-52026-01-29Oxy/Apap 5/325
67296-1392-62026-01-29Oxy/Apap 5/325
67296-1392-72026-01-29Oxy/Apap 5/325
67296-1392-82026-01-29Oxy/Apap 5/325
67296-1392-92026-01-29Oxy/Apap 5/325
67296-1392-02024-08-07Oxy/Apap 5/325
67296-1392-12024-08-07Oxy/Apap 5/325
67296-1392-22024-08-07Oxy/Apap 5/325
67296-1392-32024-08-07Oxy/Apap 5/325
67296-1392-42024-08-07Oxy/Apap 5/325
67296-1392-52024-08-07Oxy/Apap 5/325
67296-1392-62024-08-07Oxy/Apap 5/325
67296-1392-72024-08-07Oxy/Apap 5/325
67296-1392-82024-08-07Oxy/Apap 5/325
67296-1392-92024-08-07Oxy/Apap 5/325
67296-1392-02024-01-30Oxy/Apap 5/325
67296-1392-12024-01-30Oxy/Apap 5/325
67296-1392-22024-01-30Oxy/Apap 5/325
67296-1392-32024-01-30Oxy/Apap 5/325
67296-1392-42024-01-30Oxy/Apap 5/325
67296-1392-52024-01-30Oxy/Apap 5/325
67296-1392-62024-01-30Oxy/Apap 5/325
67296-1392-72024-01-30Oxy/Apap 5/325
67296-1392-82024-01-30Oxy/Apap 5/325
67296-1392-92024-01-30Oxy/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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 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
67296-1392-76729613920715 TABLET in 1 BOTTLE (67296-1392-7) 15 tablet2016-12-010000-00-00NoNoCurrent