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 4 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE	A-S Medication Solutions	55e262d9-d9dd-43a3-bc74-35e46dd391be	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	A-S Medication Solutions	949f7347-8c3a-43ce-b975-8d187096f09f	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
DRAMAMINE - N	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	7fec7791-c242-4e43-8184-32820e657afb	2024-10-25	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	f8cf751a-9f19-4744-a350-cd22303435ee	2024-10-25	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	NCS HealthCare of KY, LLC dba Vangard Labs	1a33dec1-8d59-48bd-aaef-77d162194d57	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	92e8390b-5173-4aa1-906d-35d2c0eaaaf6	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	NuCare Pharmaceuticals,Inc.	64a508ae-768a-2fba-e053-2991aa0ac42d	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	199ae195-4556-ee88-e063-6394a90a40d4	2024-06-10	Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Direct_Rx	e79ecf77-0e0a-d7ef-e053-2a95a90a5adf	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Asclemed USA, Inc.	e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	947a03c5-bca0-4d97-90b9-bcd6d6588273	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	eae4bc73-fee1-4831-b31c-8ca56fb83ad7	2023-12-03	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine HCl	MECLIZINE HYDROCHLORIDE	BluePoint Laboratories	d9cae5a6-8d4b-bdaf-e053-2995a90a7d44	2023-11-17	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
ZenTrip Motion Sickness	MECLIZINE HYDROCHLORIDE	Sato Pharmaceutical Co., LTD	bd86c4c7-b6f0-e3e8-e053-2995a90a4454	2023-11-03	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE	Amneal Pharmaceuticals LLC	666dc4d8-7b16-4c3c-84e4-645548dbee68	2023-09-28	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	Aurobindo Pharma Limited	beb3c7f2-c0f4-41d9-a903-63a6847e0997	2023-09-15	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Zydus Lifesciences Limited	cf157a71-f80a-4fb7-b892-7102b65a8ec0	2023-08-28	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	51c96c7a-0a38-41a5-a6c9-7f45db65fdda	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	b91435d1-fb95-4939-8478-84e41f44f732	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	6a8cbc12-0725-4462-bb71-0b18cefc19e7	2023-01-01	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