Oxycodone and Acetaminophen

Product NDC: 10544-621
11-digit product format: 105440621
Labeler code: 10544
Product ID: 10544-621_b93cc1aa-1a9a-4e1a-9f2e-a02bf14c4ff1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA040777
Marketing category: ANDA
Marketing start: 2010-05-17
Marketing end: 0000-00-00
Substance: OXYCODONE; ACETAMINOPHEN
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-621		I	Inactivated by FDA	2026-10-05
excluded package	package	10544-621	10544-621-06	I	Inactivated by FDA	2026-10-05
excluded package	package	10544-621	10544-621-10	I	Inactivated by FDA	2026-10-05
excluded package	package	10544-621	10544-621-15	I	Inactivated by FDA	2026-10-05
excluded package	package	10544-621	10544-621-20	I	Inactivated by FDA	2026-10-05
excluded package	package	10544-621	10544-621-30	I	Inactivated by FDA	2026-10-05
excluded package	package	10544-621	10544-621-50	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 · 154 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	10544-621-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-621-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-621-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-621-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-621-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-621-30	`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	10544-621-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-621-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-621-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-621-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-621-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-621-30	`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	10544-621-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-621-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-621-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-621-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-621-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-621-30	`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	10544-621-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-621-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-621-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-621-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-621-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-621-30	`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	10544-621-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-621-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-621-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-621-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-621-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-621-30	`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	10544-621-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-621-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-621-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-621-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-621-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-621-30	`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	10544-621-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-621-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-621-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-621-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-621-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-621-30	`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	10544-621-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-621-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-621-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-621-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-621-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-621-30	`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	10544-621-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-621-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-621-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A040777-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA		2007-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040777-001	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 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	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040777-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2007-11-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A040777-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040777-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040777-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040777-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040777-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040777-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040777-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040777-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040777-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040777-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040777-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040777-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040777-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040777-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040777-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040777-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040777-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040777-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040777-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040777-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040777-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040777-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040777-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040777-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040777-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040777-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040777-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040777-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040777-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040777-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040777-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040777-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040777-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040777-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040777-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040777-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040777-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040777-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040777-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040777-001	AA	1	`f41ea6bd6efb…`

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, Related label table
NDC	Related label
10544-621-06	Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII
10544-621-10	Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII
10544-621-15	Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII
10544-621-20	Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII
10544-621-30	Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII
10544-621-50	Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-621-06	Oxycodone and Acetaminophen	6 in 1 BOTTLE	TABLET	6	1
10544-621-10	Oxycodone and Acetaminophen	10 in 1 BOTTLE	TABLET	10	1
10544-621-15	Oxycodone and Acetaminophen	15 in 1 BOTTLE	TABLET	15	1
10544-621-20	Oxycodone and Acetaminophen	20 in 1 BOTTLE	TABLET	20	1
10544-621-30	Oxycodone and Acetaminophen	30 in 1 BOTTLE	TABLET	30	1
10544-621-50	Oxycodone and Acetaminophen	50 in 1 BOTTLE	TABLET	50	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-621-10	EA - Each	10544-621	c79776cc-618d-47b5-b5a0-ca31fc901df2	1	2015-10-02
10544-621-30	EA - Each	10544-621	7798c87f-10f6-4f74-989e-ac3178692f37	1	2015-10-02
10544-621-50	EA - Each	10544-621	038cfade-f2a5-4a1f-923c-faaf959e626c	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
OXYCODONE	ACTIVE INGREDIENT	CD35PMG570	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-621	OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 6 package rows	20101018_26c17ac7-64f4-436b-a56d-38d4584959e8.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 · 2 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): 040777 application number: ANDA040777
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Amneal Pharmaceuticals of New York LLC	683d563f-0686-4964-8183-cf08758cae71	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040777 application number: ANDA040777

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CD35PMG570	OXYCODONE	76-42-6	OXYCODONE
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	26c17ac7-64f4-436b-a56d-38d4584959e8	1
1049221	acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	26c17ac7-64f4-436b-a56d-38d4584959e8	1
1049221	APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SY	26c17ac7-64f4-436b-a56d-38d4584959e8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-621-06	10544062106	6 in 1 BOTTLE	Historical
10544-621-10	10544062110	10 in 1 BOTTLE	Historical
10544-621-15	10544062115	15 in 1 BOTTLE	Historical
10544-621-20	10544062120	20 in 1 BOTTLE	Historical
10544-621-30	10544062130	30 in 1 BOTTLE	Historical
10544-621-50	10544062150	50 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII	Blenheim Pharmacal, Inc.	2010-10-18	HUMAN PRESCRIPTION DRUG LABEL	1