Application 213957

Type: ANDA
Sponsor: ZYDUS

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	No
002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

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

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
A213957-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA		2020-06-23
A213957-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2020-06-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213957-001	AA
A213957-002	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 · 74 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
2026-02-19 14:30 UTC	2026-02	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A213957-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213957-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213957-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213957-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213957-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213957-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213957-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213957-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213957-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213957-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213957-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213957-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213957-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213957-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213957-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213957-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-002	AA	1	`87673890dc5c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Redpharm Drug	53df5b1b-64da-e805-e063-6294a90a0a55	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Redpharm Drug	37457bd5-2fdd-b829-e063-6294a90a04f0	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2990e296-2d60-70c0-e063-6394a90abbe4	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2e0ed1fc-53e6-a3b1-e063-6394a90af419	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	947a03c5-bca0-4d97-90b9-bcd6d6588273	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957 ndc (product): 70710-1162 ndc (product): 70710-1161
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	eae4bc73-fee1-4831-b31c-8ca56fb83ad7	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957 ndc (product): 50090-5728
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Zydus Lifesciences Limited	cf157a71-f80a-4fb7-b892-7102b65a8ec0	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957 ndc (product): 70771-1540 ndc (product): 70771-1539
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	51c96c7a-0a38-41a5-a6c9-7f45db65fdda	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5728	Meclizine Hydrochloride	Meclizine Hydrochloride	A-S Medication Solutions	ANDA	Current
70710-1161	Meclizine Hydrochloride	Meclizine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1162	Meclizine Hydrochloride	Meclizine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1539	Meclizine Hydrochloride	Meclizine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1540	Meclizine Hydrochloride	Meclizine Hydrochloride	Cadila Healthcare Limited	ANDA	Current