Application 040863

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	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
A040863-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30
A040863-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30
A040863-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040863-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040863-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2008-12-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

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	A040863-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040863-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040863-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040863-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040863-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040863-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040863-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040863-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040863-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040863-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040863-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040863-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040863-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040863-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040863-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040863-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040863-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040863-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040863-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040863-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040863-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040863-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040863-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040863-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040863-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040863-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040863-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040863-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040863-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040863-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040863-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040863-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040863-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040863-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040863-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040863-003	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A040863-001	AB	1	`ea1830bbd6c7…`

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7668	promethazine hydrochloride	promethazine hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-941	promethazine hydrochloride	promethazine hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
57664-107	promethazine hydrochloride	promethazine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-108	promethazine hydrochloride	promethazine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-109	promethazine hydrochloride	promethazine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
61919-396	PHENERGAN	PROMWTHAZINE	DIRECT RX	ANDA	Current
61919-396	PHENERGAN	PROMWTHAZINE	DIRECT RX	ANDA	Current
61919-630	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-630	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-630	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
63187-038	promethazine hydrochloride	promethazine hydrochloride	Proficient Rx LP	ANDA	Current
63187-038	promethazine hydrochloride	promethazine hydrochloride	Proficient Rx LP	ANDA	Current
66267-177	promethazine hydrochloride	promethazine hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-177	promethazine hydrochloride	promethazine hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-813	promethazine hydrochloride	promethazine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-0109	promethazine hydrochloride	promethazine hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0109	promethazine hydrochloride	promethazine hydrochloride	Bryant Ranch Prepack	ANDA	Current