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 3 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	MECLIZINE HYDROCHLORIDE	TARGET CORPORATION	36ba2950-4a09-e5de-e063-6394a90a1771	2025-09-04	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6c66ee38-10bb-4559-9d2f-51e6d6f091ee	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	112103bc-25e2-42cf-8542-ba1d3392a2c3	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	27b6a7e0-a361-4705-9f31-719063a65f22	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Jubilant Cadista Pharmacuticals Inc.	9350fefc-9c00-182c-c3a9-044d4a40856f	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	American Health Packaging	af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2990e296-2d60-70c0-e063-6394a90abbe4	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
BONINE MAX	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	7326a47e-284e-4b6f-8eb0-7933dc1e3f0d	2025-04-11	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
BONINE	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	2025-03-21	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
BONINE	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	0b2ea6b8-b342-4940-8922-898758fbeb31	2025-03-21	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Chartwell RX, LLC	87d4c6d8-9218-48c2-9163-615a32449f11	2025-03-14	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Walgreen Company	ecf8d05e-0e77-f3e8-e053-2a95a90a6604	2025-03-11	Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2e0ed1fc-53e6-a3b1-e063-6394a90af419	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2d31ae73-3f09-a77c-e063-6294a90ade9a	2025-02-02	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	DirectRx	d27fe828-4fee-3ba9-e053-2995a90ae7b6	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	e4d785a7-a688-3acb-e053-2a95a90a6d2e	2025-01-09	Boxed warning, Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	ed43bf21-f3da-245c-e053-2995a90a504c	2025-01-09	Boxed warning, Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine	MECLIZINE HYDROCHLORIDE	Advanced Rx LLC	b0a2a1f7-354e-48bd-9e98-9207bf9f53fd	2024-11-27	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine HCl	MECLIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	acdf636c-66f1-4a1f-87a8-786f51d75708	2024-11-13	Warnings	Name fallback 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