Application 200294

Type: ANDA
Sponsor: EPIC PHARMA LLC

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 42.

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
A200294-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA		2012-04-13
A200294-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2012-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200294-001	AA
A200294-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200294-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200294-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200294-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200294-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200294-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200294-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200294-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200294-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200294-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200294-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200294-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200294-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200294-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200294-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200294-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200294-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200294-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200294-002	AA	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	91b1fd1a-1da2-4aae-826f-7de0bfe62161	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200294 application number: ANDA200294 ndc (product): 63187-258
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Epic Pharma LLC	467e464b-bbaf-4053-9136-39e47a92fa05	2020-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200294 application number: ANDA200294 ndc (product): 42806-014 ndc (product): 42806-012

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8052	Meclizine Hydrochloride	Meclizine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8052	Meclizine Hydrochloride	Meclizine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
12634-424	Meclizine Hydrochloride	Meclizine Hydrochloride	Apotheca Inc.	ANDA	Current
42806-012	Meclizine Hydrochloride	Meclizine Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-012	Meclizine Hydrochloride	Meclizine Hydrochloride	Epic Pharma LLC	ANDA	Current
42806-012	Meclizine Hydrochloride	Meclizine Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-014	Meclizine Hydrochloride	Meclizine Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-014	Meclizine Hydrochloride	Meclizine Hydrochloride	Epic Pharma LLC	ANDA	Current
42806-014	Meclizine Hydrochloride	Meclizine Hydrochloride	Epic Pharma, LLC	ANDA	Current
50436-0014	Meclizine Hydrochloride	Meclizine Hydrochloride	Unit Dose Services	ANDA	Current
60760-425	Meclizine Hydrochloride	Meclizine Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-301	MECLIZINE	MECLIZINE	DIRECT RX	ANDA	Current
61919-301	MECLIZINE	MECLIZINE	DIRECT RX	ANDA	Current
61919-752	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	DirectRX	ANDA	Current
63187-258	Meclizine Hydrochloride	Meclizine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-258	Meclizine Hydrochloride	Meclizine Hydrochloride	Proficient Rx LP	ANDA	Current
66267-138	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-138	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-139	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-139	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-800	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-800	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-801	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-801	Meclizine Hydrochloride	Meclizine Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
67296-1309	Meclizine Hydrochloride	Meclizine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1309	Meclizine Hydrochloride	Meclizine Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
69677-153	Meclizine Hydrochloride	Meclizine Hydrochloride	MAS MANAGEMENT GROUP, INC.	ANDA	Current
70518-0421	Meclizine Hydrochloride	Meclizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0422	Meclizine Hydrochloride	Meclizine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0189	Meclizine Hydrochloride	Meclizine Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43344	ORIG	2012-06-22