Application 040654

Type: ANDA
Sponsor: VINTAGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	5MG/5ML;6.25MG/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040654-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040654-001	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	5MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2006-12-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040654-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040654-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040654-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040654-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040654-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040654-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040654-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040654-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040654-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040654-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040654-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040654-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040654-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040654-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040654-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040654-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040654-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040654-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040654-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040654-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040654-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040654-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040654-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040654-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040654-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040654-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040654-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040654-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040654-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040654-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040654-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040654-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040654-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040654-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040654-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040654-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040654-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040654-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040654-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040654-001	AA	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Phenylephrine Hydrochloride	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Genus Lifesciences Inc.	7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040654 application number: ANDA040654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0926	Promethazine VC	Promethazine Hydrochloride and Phenylephrine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0603-1587	Promethazine VC	Promethazine hydrochloride and phenylephrine hydrochloride	Par Pharmaceutical	ANDA	Current
0603-1587	Promethazine VC	Promethazine hydrochloride and phenylephrine hydrochloride	Par Pharmaceutical	ANDA	Current
68788-6763	Promethazine VC	Promethazinehydrochloride and phenylephrine hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9100	Promethazine VC	Promethazinehydrochloride and phenylephrine hydrochloride	Preferred Pharmaceuticals, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23716	ORIG	2006-12-18