Application 077723

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	7.5MG;200MG	No	No
002	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	10MG;200MG	No	No
003	HYDROCODONE	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	5MG;200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET / ORAL	2006-11-06
A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET / ORAL	2006-11-06
A077723-003	HYDROCODONE	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET / ORAL	2006-11-06

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 · 120 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	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077723-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077723-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077723-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077723-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077723-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077723-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077723-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077723-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077723-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077723-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077723-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077723-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077723-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077723-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077723-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077723-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077723-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077723-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077723-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077723-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077723-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077723-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077723-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077723-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077723-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077723-003	AB	1	`cb3db0bc1861…`

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
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Aurolife Pharma, LLC	470df63a-5c0f-42df-9023-a330a901153e	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydrocodone Bitartrate and Ibuprofen
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Amneal Pharmaceuticals of New York LLC	abc33718-4e88-43ea-9ffa-2b04ffc812ef	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Hydrocodone Bitartrate and Ibuprofen

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical, Inc.	ANDA	Current
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3897	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3897	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3897	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
50991-579	IBUDONE	hydrocodone bitartrate and ibuprofen	Poly Pharmaceuticals	ANDA	Current
55700-639	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-296	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76162	ORIG	2023-11-03