Application 040777

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;5MG	No	No

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A040777-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040777-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040777-001	AA	1	`a50c72e98297…`

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 ndc (product): 50268-644
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 ndc (product): 53746-203

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-621	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Blenheim Pharmacal, Inc.	ANDA	Current
35356-817	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
45865-860	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Medsource Pharmaceuticals	ANDA	Current
50268-644	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvPAK	ANDA	Current
50268-644	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	AvPAK	ANDA	Current
50436-0203	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Unit Dose Services	ANDA	Current
53746-203	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-203	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-203	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-203	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-203	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
60760-200	Oxycodone Hydrochloride and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-614	OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	DIRECT RX	ANDA	Current
63739-709	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-709	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	McKesson Corporation	ANDA	Current
67296-0522	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	RedPharm Drug Inc.	ANDA	Current
68084-355	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	American Health Packaging	ANDA	Current
68084-355	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	American Health Packaging	ANDA	Current
68084-355	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	American Health Packaging	ANDA	Current
68084-355	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	American Health Packaging	ANDA	Current
68084-355	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	American Health Packaging	ANDA	Current
68094-013	Oxycodone and Acetaminophen	Oxycodone Hydrochloride and Acetaminophen	Precision Dose, Inc.	ANDA	Current
71335-0193	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-0193	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-0193	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76299	ORIG	2023-11-03