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 3 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97	2025-10-20	Boxed warning, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d766cf7-a21c-4eaf-bbdc-00f2939ef19a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Major Pharmaceuticals	4cee8622-7d59-4794-8e32-54f7aac1d923	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	BluePoint Laboratories	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	7a186bcd-ab8c-4695-8289-4cd33bb551cf	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	13d9e59d-eadb-41d5-9f47-9c11a6efb31c	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	d545105f-27dc-4820-b0b1-fcf17e0be0f0	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	6f7e47cc-f823-4336-8107-f980e3049617	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	1b1cee64-c0b5-4da6-92d0-1769350a5181	2025-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Xttrium Laboratories, Inc.	302bfea2-d403-d315-e063-6294a90a37dd	2025-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Kesin Pharma Corporation	28793bd2-bd40-4571-e063-6394a90ae789	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	74834e1b-0d90-0542-e053-2991aa0aa1ef	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	2d996287-9eed-265a-e063-6294a90a6969	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	12400c65-f93b-47a5-8167-1fb14337130b	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c23037-e415-7604-e053-2995a90a5bb6	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	4eaa8291-9cde-4205-857b-925ea8d618ba	2024-12-04		Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	05907a49-537f-4bf2-8a5f-5e905f19fece	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	6aa6bfcc-024b-4ee2-a586-6c4ca879cea4	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	69eea039-0098-4e2f-a832-152583b16f05	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b7137912-d119-4899-9c93-09c1c625f290	2024-10-21	Boxed warning, 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