Application 084657

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084657-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982
A084657-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`

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	A084657-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084657-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084657-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084657-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084657-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A084657-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084657-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084657-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084657-002	AA	1	`782e0a99824c…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084657-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084657-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084657-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084657-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084657-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A084657-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084657-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A084657-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084657-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084657-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084657-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A084657-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084657-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A084657-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084657-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084657-002	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 · 85 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Proficient Rx LP	f574e123-8db7-4e3d-a0ee-e4e1f04ff146	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	91b1fd1a-1da2-4aae-826f-7de0bfe62161	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Asclemed USA, Inc.	5c70e61b-a1e6-4981-92e2-1050cee08baa	2020-10-30	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Epic Pharma LLC	467e464b-bbaf-4053-9136-39e47a92fa05	2020-08-21	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	53f410fd-104c-42c1-9740-6f48ffbc974f	2020-05-22	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE 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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-629	Meclizine Hydrochloride	Meclizine Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60760-842	Meclizine Hydrochloride	Meclizine Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
62559-841	Meclizine Hydrochloride	Meclizine Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-842	Meclizine Hydrochloride	Meclizine Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
68071-2697	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2697	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2817	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-2137	Meclizine Hydrochloride	Meclizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-9619	Meclizine Hydrochloride	Meclizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current