Oxycodone and Acetaminophen

Product NDC: 52959-119
11-digit product format: 529590119
Labeler code: 52959
Product ID: 52959-119_91b582b6-c0b5-477e-bf84-cb198a6151bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA040778
Marketing category: ANDA
Marketing start: 2007-11-27
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: E
Listing certified through: 2018-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-119		I	Inactivated by FDA	2026-10-05
excluded package	package	52959-119	52959-119-02	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-119	52959-119-20	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-119	52959-119-30	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-119	52959-119-60	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-119	52959-119-90	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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-119-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-119-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-119-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-119-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-119-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-119-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-119-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-119-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-119-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-119-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-119-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-119-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-119-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-119-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-119-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-119-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-119-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-119-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-119-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-119-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-119-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-119-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-119-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-119-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-119-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-119-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-119-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-119-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-119-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-119-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-119-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-119-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-119-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-119-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-119-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-119-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-119-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-119-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-119-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-119-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-119-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-119-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-119-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-119-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-119-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-119-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-119-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-119-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-119-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-119-30	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040778-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA		2007-11-27
A040778-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA		2014-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040778-001	AA
A040778-002	AA

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 3 · 86 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	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040778-001	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2007-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040778-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2014-06-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040778-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040778-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040778-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040778-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040778-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040778-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040778-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040778-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040778-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040778-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040778-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040778-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040778-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040778-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040778-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040778-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040778-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040778-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040778-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040778-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040778-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040778-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040778-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040778-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040778-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040778-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040778-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040778-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040778-002	AA	1	`74a2ff9319b5…`

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
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
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
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
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
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	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
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-119-02	Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-20	Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-30	Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-60	Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII
52959-119-90	Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-119-02	Oxycodone and Acetaminophen	120 in 1 BOTTLE	TABLET	120	2
52959-119-20	Oxycodone and Acetaminophen	20 in 1 BOTTLE	TABLET	20	2
52959-119-30	Oxycodone and Acetaminophen	30 in 1 BOTTLE	TABLET	30	2
52959-119-60	Oxycodone and Acetaminophen	60 in 1 BOTTLE	TABLET	60	2
52959-119-90	Oxycodone and Acetaminophen	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-119-02	EA - Each	52959-119	b5882710-43f7-4a20-a4d9-b91977fec438	1	2012-07-24
52959-119-20	EA - Each	52959-119	f28da205-5f83-4113-97bc-d40a1649c296	1	2012-07-24
52959-119-30	EA - Each	52959-119	7301bc7e-05ec-4f44-8f01-96efca34a479	1	2012-07-24
52959-119-60	EA - Each	52959-119	04436a32-4ce7-492c-b115-b080a7c59e53	1	2012-07-24
52959-119-90	EA - Each	52959-119	fea9091b-774e-4db4-982c-f19ee04e91bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-119	OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 5 package rows	20110902_a6cce10a-23ba-4eb1-9b1b-0f962f42df81.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	AvPAK	7055acd5-1cbb-397e-e053-2a91aa0a3852	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals of New York LLC	d61e0ff4-e04b-4dc6-b818-6a8f46e99b5e	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals LLC	c5cc2e88-aa00-46bd-91dc-901c3a7c899c	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	6253b3ae-bb52-4532-8d1f-756c0b1577c7	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040778 application number: ANDA040778

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
1049214	oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet	PSN	a6cce10a-23ba-4eb1-9b1b-0f962f42df81	2
1049214	acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SCD	a6cce10a-23ba-4eb1-9b1b-0f962f42df81	2
1049214	APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SY	a6cce10a-23ba-4eb1-9b1b-0f962f42df81	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-119-02	52959011902	120 in 1 BOTTLE	Historical
52959-119-20	52959011920	20 in 1 BOTTLE	Historical
52959-119-30	52959011930	30 in 1 BOTTLE	Historical
52959-119-60	52959011960	60 in 1 BOTTLE	Historical
52959-119-90	52959011990	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII	H.J. Harkins Company, Inc. \| Amneal Pharmaceuticals	2011-08-31	HUMAN PRESCRIPTION DRUG LABEL	2