Application 040882

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	6.25MG/5ML	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
A040882-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL			2009-12-30

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	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL		2009-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040882-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-12-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040882-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040882-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040882-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040882-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040882-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040882-001	AA	1	`782e0a99824c…`
2021-03-12 10:30 UTC	2021-03	A040882-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040882-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040882-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040882-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040882-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040882-001	AA	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040882-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040882-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040882-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040882-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040882-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040882-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040882-001	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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b96904e7-cc67-4abc-b946-8423f3f897ff	2023-10-24	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	c0a68671-407b-4840-9662-04f168cff1cb	2023-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: promethazine hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	2023-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	677b5fc5-94be-638b-e053-2991aa0a7f97	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	2c9a4767-23c4-4a1c-bb4c-2bad1351c270	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	dc8b50de-e4f6-607f-e053-2995a90a2902	2023-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	dcb1694a-8451-403c-b848-edb89ba17020	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	32022e66-6f76-430a-8ad2-1e9e2872fee1	2023-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	87429921-00d2-42c7-9e99-600e8075b8ce	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	c930985b-bba3-4f3a-a1ae-1d808670efde	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	59b906c6-2ccc-416e-b3ee-db09bf553146	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	ba7d9e82-9b13-4607-b2f9-25e575b8c73b	2022-11-05	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	29a8b172-1bad-40db-8d73-1fe7fb309cff	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	08bf9fbf-cc21-41a0-9e81-ec498aa64170	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Actavis Pharma, Inc.	a32255f0-0077-489e-bdc6-869aca8cd434	2016-12-01	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-678	Promethazine Hydrochloride	Promethazine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-678	Promethazine Hydrochloride	Promethazine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-678	Promethazine Hydrochloride	Promethazine	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
65162-678	Promethazine Hydrochloride	Promethazine	Amneal Pharmaceuticals LLC	ANDA	Current