Application 040330

Type: ANDA
Sponsor: VINTAGE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;2.5MG	No	Yes
002	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;5MG	No	Yes
003	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	Yes
004	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040330-001	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25
A040330-002	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25
A040330-003	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23
A040330-004	PERCOCET	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A040330-001	AA
A040330-002	AA
A040330-003	AA
A040330-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-001	PERCOCET	325MG;2.5MG	TABLET / ORAL	AA	RS	1999-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-002	PERCOCET	325MG;5MG	TABLET / ORAL	AA	RS	1999-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-003	PERCOCET	325MG;7.5MG	TABLET / ORAL	AA	RS	2001-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-004	PERCOCET	325MG;10MG	TABLET / ORAL	AA	RS	2001-11-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040330-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040330-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040330-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040330-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040330-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040330-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040330-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040330-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040330-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040330-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040330-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040330-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040330-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040330-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040330-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040330-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040330-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040330-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040330-004	AA	1	`d8e5a09893c0…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PERCOCET	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	SpecGx LLC	4dd36cf5-8f73-404a-8b1d-3bd53bd90c25	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040330 application number: ANDA040330 ndc (product): 63481-623 ndc (product): 63481-627 ndc (product): 63481-628 ndc (product): 63481-629
ENDOCET	OXYCODONE AND ACETAMINOPHEN	Par Health USA, LLC	944d3e60-7eee-11de-a413-0002a5d5c51b	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040330 application number: ANDA040330 ndc (product): 60951-602 ndc (product): 60951-700 ndc (product): 60951-701 ndc (product): 60951-712
ENDOCET	OXYCODONE AND ACETAMINOPHEN	Redpharm Drug	3251c37b-8e31-a613-e063-6294a90ae982	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040330 application number: ANDA040330
ENDOCET	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	7dc10b86-c6cd-4012-b7b9-b694ccf4f768	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040330 application number: ANDA040330
ENDOCET	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	f11f356e-967d-4099-9d87-5497790b397c	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040330 application number: ANDA040330 ndc (product): 71335-2182
ENDOCET	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040330 application number: ANDA040330 ndc (product): 63629-2190

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12634-942	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	Apotheca, Inc	ANDA	Current
60951-602	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical	ANDA	Current
60951-602	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-602	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-700	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical	ANDA	Current
60951-700	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-700	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-701	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical	ANDA	Current
60951-701	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-701	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-712	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical	ANDA	Current
60951-712	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
60951-712	ENDOCET	Oxycodone and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
63481-623	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-623	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals, Inc.	ANDA	Current
63481-623	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-627	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-627	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals, Inc.	ANDA	Current
63481-627	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-628	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-628	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals, Inc.	ANDA	Current
63481-628	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-629	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63481-629	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals, Inc.	ANDA	Current
63481-629	PERCOCET	oxycodone hydrochloride and acetaminophen	Endo Pharmaceuticals Inc.	ANDA	Current
63629-2187	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2187	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2188	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2188	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2189	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2189	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2190	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2190	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
65084-298	PERCOCET	oxycodone hydrochloride and acetaminophen	Mckesson Rxpak Inc	ANDA	Current
71335-2182	ENDOCET	Oxycodone and Acetaminophen	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76186	ORIG	2023-11-03
59118	SUPPL	2019-06-19
59117	SUPPL	2019-06-19
38884	SUPPL	2006-11-30
22127	ORIG	1999-06-25
7625	ORIG	1999-06-25