Application 201451

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	Yes
002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	Yes
003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	RLD / RS	Approval date
A201451-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23
A201451-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23
A201451-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201451-001	AA
A201451-002	AA
A201451-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201451-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201451-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201451-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201451-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201451-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201451-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201451-001	AA	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	1b541252-e8a7-b678-e063-6394a90a34dc	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Major Pharmaceuticals	f99f13ab-33c0-4304-8dc5-3a75f3909377	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	QPharma Inc	2df6edde-4479-ed9d-e063-6394a90abdc1	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ff719d9c-8d80-42db-97a5-022a75773623	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE	AvPAK	af5d0c9b-a997-8033-afca-3c04221f2e76	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b4716c-411a-62cd-e053-2a95a90a6f4b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	QPharma Inc	18fe5e13-5583-45ee-ab6e-32e9af426bd8	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	American Health Packaging	af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE	Amneal Pharmaceuticals LLC	666dc4d8-7b16-4c3c-84e4-645548dbee68	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0732	Meclizine Hydrochloride	Meclizine	Bryant Ranch Prepack	ANDA	Current
71335-0732	Meclizine Hydrochloride	Meclizine	Bryant Ranch Prepack	ANDA	Current
71335-0814	Meclizine Hydrochloride	Meclizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0814	Meclizine Hydrochloride	Meclizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0814	Meclizine Hydrochloride	Meclizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-048	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
72189-048	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current
72189-048	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Direct_Rx	ANDA	Current