Application 040891

Type: ANDA
Sponsor: NOSTRUM LABS INC

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 42.

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
A040891-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA		2009-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040891-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040891-001	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	2009-03-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040891-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040891-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040891-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040891-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040891-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040891-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040891-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040891-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040891-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040891-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040891-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040891-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040891-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040891-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040891-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040891-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040891-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040891-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040891-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040891-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040891-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040891-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040891-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040891-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040891-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040891-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040891-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040891-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040891-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040891-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040891-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040891-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040891-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040891-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040891-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040891-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040891-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040891-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040891-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040891-001	AA	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Kesin Pharma Corporation	28793bd2-bd40-4571-e063-6394a90ae789	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040891 application number: ANDA040891
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	a4b3da5b-1129-43c2-bf22-3a29c3fae116	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040891 application number: ANDA040891

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63187-858	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-858	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63629-9151	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-9151	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
68151-0146	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Carilion Materials Management	ANDA	Current
70408-146	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Nostrum Laboratories, Inc.	ANDA	Current
70408-146	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Nostrum Laboratories, Inc.	ANDA	Current