Oxycodone and Acetaminophen

Product NDC: 67296-1301
Requested package NDC: 67296-1301-6
11-digit product format: 672961301
Labeler code: 67296
Product ID: 67296-1301_9c9f6aa8-6028-16ad-e053-2995a90af810
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc,
Application: ANDA040105
Marketing category: ANDA
Marketing start: 1996-07-30
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 5 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1301	67296-1301-6	I	Inactivated by FDA		2026-10-05

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 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040105-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL			1996-07-30

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	1996-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040105-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		1996-07-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040105-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040105-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040105-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040105-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040105-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040105-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040105-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040105-001	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6	Product name	1	20170628
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
68d3ff71-7803-4cf4-ba84-71ce4712df22	Product name	1	20160620
07e5b999-fda7-79c9-8f77-8380537ade79	Product name	4	20160517
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1301-1	2022-01-28	C162847	48780-1	d6a99b39-9fba-a426-e053-dadaa90af4c2	4fe2cf36-625d-12ef-e054-00144ff88e88
67296-1301-6	2022-01-28	C162847	48780-1	d6a99b39-9fba-a426-e053-dadaa90af4c2	4fe2cf36-625d-12ef-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1301-1	Oxycodone and Acetaminophen	10 in 1 BOTTLE	TABLET	10		2
67296-1301-6	Oxycodone and Acetaminophen	6 in 1 BOTTLE	TABLET	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1301	OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC,]	2	Legacy NDC, 2 package rows	20200121_4fe2cf36-625d-12ef-e054-00144ff88e88.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049221	oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet	PSN	4fe2cf36-625d-12ef-e054-00144ff88e88	2
1049221	acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	4fe2cf36-625d-12ef-e054-00144ff88e88	2
1049221	APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SY	4fe2cf36-625d-12ef-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1301-6	67296130106	6 TABLET in 1 BOTTLE (67296-1301-6)	6 tablet	1996-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen - RedPharm Drug, Inc, \| RedPharm Drug, Inc.	RedPharm Drug, Inc, \| RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2