Application 077727

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	5MG;200MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077727-001	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077727-001	AB	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A077727-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077727-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077727-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077727-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077727-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077727-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077727-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077727-001	AB	1	`ea99ee380514…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-3584	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3584	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3584	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current