Meclizine Hydrochloride

Product NDC: 12634-424
11-digit product format: 126340424
Labeler code: 12634
Product ID: 12634-424_46f1e0ac-d67e-4419-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA200294
Marketing category: ANDA
Marketing start: 2012-04-30
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 39 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-424		I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-00	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-01	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-09	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-12	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-18	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-40	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-42	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-45	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-50	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-52	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-54	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-57	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-59	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-60	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-61	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-63	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-66	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-67	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-69	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-71	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-74	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-78	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-79	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-80	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-81	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-82	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-84	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-85	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-90	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-91	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-92	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-93	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-94	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-95	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-96	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-97	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-98	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-424	12634-424-99	I	Inactivated by FDA	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 11 · 624 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-424-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-424-52	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A200294-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200294-002	AA	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-424-00	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-01	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-09	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-12	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-18	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-40	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-42	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-45	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-50	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-52	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-54	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-57	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-59	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-60	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-61	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-63	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-66	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-67	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-69	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-71	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-74	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-78	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-79	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-80	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-81	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-82	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-84	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-85	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-90	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-91	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-92	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-93	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-94	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-95	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-96	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-97	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-98	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
12634-424-99	Meclizine Hydrochloride Tablets USP, 25 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-424-00	Meclizine Hydrochloride	10 in 1 BOTTLE	TABLET	10	1
12634-424-01	Meclizine Hydrochloride	100 in 1 BOTTLE	TABLET	100	1
12634-424-09	Meclizine Hydrochloride	35 in 1 BOTTLE	TABLET	35	1
12634-424-12	Meclizine Hydrochloride	120 in 1 BOTTLE	TABLET	120	1
12634-424-18	Meclizine Hydrochloride	180 in 1 BOTTLE	TABLET	180	1
12634-424-40	Meclizine Hydrochloride	40 in 1 BOTTLE	TABLET	40	1
12634-424-42	Meclizine Hydrochloride	42 in 1 BOTTLE	TABLET	42	1
12634-424-45	Meclizine Hydrochloride	45 in 1 BOTTLE	TABLET	45	1
12634-424-50	Meclizine Hydrochloride	50 in 1 BOTTLE	TABLET	50	1
12634-424-52	Meclizine Hydrochloride	12 in 1 BLISTER PACK	TABLET	12	1
12634-424-54	Meclizine Hydrochloride	14 in 1 BLISTER PACK	TABLET	14	1
12634-424-57	Meclizine Hydrochloride	20 in 1 BLISTER PACK	TABLET	20	1
12634-424-59	Meclizine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	1
12634-424-60	Meclizine Hydrochloride	60 in 1 BOTTLE	TABLET	60	1
12634-424-61	Meclizine Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	1
12634-424-63	Meclizine Hydrochloride	3 in 1 BLISTER PACK	TABLET	3	1
12634-424-66	Meclizine Hydrochloride	6 in 1 BLISTER PACK	TABLET	6	1
12634-424-67	Meclizine Hydrochloride	7 in 1 BLISTER PACK	TABLET	7	1
12634-424-69	Meclizine Hydrochloride	9 in 1 BLISTER PACK	TABLET	9	1
12634-424-71	Meclizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	1
12634-424-74	Meclizine Hydrochloride	24 in 1 BOTTLE	TABLET	24	1
12634-424-78	Meclizine Hydrochloride	28 in 1 BOTTLE	TABLET	28	1
12634-424-79	Meclizine Hydrochloride	25 in 1 BOTTLE	TABLET	25	1
12634-424-80	Meclizine Hydrochloride	20 in 1 BOTTLE	TABLET	20	1
12634-424-81	Meclizine Hydrochloride	21 in 1 BOTTLE	TABLET	21	1
12634-424-82	Meclizine Hydrochloride	12 in 1 BOTTLE	TABLET	12	1
12634-424-84	Meclizine Hydrochloride	14 in 1 BOTTLE	TABLET	14	1
12634-424-85	Meclizine Hydrochloride	15 in 1 BOTTLE	TABLET	15	1
12634-424-90	Meclizine Hydrochloride	90 in 1 BOTTLE	TABLET	90	1
12634-424-91	Meclizine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1	1
12634-424-92	Meclizine Hydrochloride	2 in 1 BOTTLE	TABLET	2	1
12634-424-93	Meclizine Hydrochloride	3 in 1 BOTTLE	TABLET	3	1
12634-424-94	Meclizine Hydrochloride	4 in 1 BOTTLE	TABLET	4	1
12634-424-95	Meclizine Hydrochloride	5 in 1 BOTTLE	TABLET	5	1
12634-424-96	Meclizine Hydrochloride	6 in 1 BOTTLE	TABLET	6	1
12634-424-97	Meclizine Hydrochloride	7 in 1 BOTTLE	TABLET	7	1
12634-424-98	Meclizine Hydrochloride	8 in 1 BOTTLE	TABLET	8	1
12634-424-99	Meclizine Hydrochloride	9 in 1 BOTTLE	TABLET	9	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-424	MECLIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]	1	Legacy NDC, 38 package rows	20170126_46f1e0ac-d67d-4419-e054-00144ff88e88.zip

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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995666	meclizine HCl 25 MG Oral Tablet	PSN	46f1e0ac-d67d-4419-e054-00144ff88e88	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	46f1e0ac-d67d-4419-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12634-424-00	12634042400	10 TABLET in 1 BOTTLE (12634-424-00)	10 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-01	12634042401	100 TABLET in 1 BOTTLE (12634-424-01)	100 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-09	12634042409	35 TABLET in 1 BOTTLE (12634-424-09)	35 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-12	12634042412	120 TABLET in 1 BOTTLE (12634-424-12)	120 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-18	12634042418	180 TABLET in 1 BOTTLE (12634-424-18)	180 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-40	12634042440	40 TABLET in 1 BOTTLE (12634-424-40)	40 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-42	12634042442	42 TABLET in 1 BOTTLE (12634-424-42)	42 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-45	12634042445	45 TABLET in 1 BOTTLE (12634-424-45)	45 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-50	12634042450	50 TABLET in 1 BOTTLE (12634-424-50)	50 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-52	12634042452	12 TABLET in 1 BLISTER PACK (12634-424-52)	12 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-54	12634042454	14 TABLET in 1 BLISTER PACK (12634-424-54)	14 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-57	12634042457	20 TABLET in 1 BLISTER PACK (12634-424-57)	20 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-59	12634042459	30 TABLET in 1 BLISTER PACK (12634-424-59)	30 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-60	12634042460	60 TABLET in 1 BOTTLE (12634-424-60)	60 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-61	12634042461	10 TABLET in 1 BLISTER PACK (12634-424-61)	10 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-63	12634042463	3 TABLET in 1 BLISTER PACK (12634-424-63)	3 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-66	12634042466	6 TABLET in 1 BLISTER PACK (12634-424-66)	6 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-67	12634042467	7 TABLET in 1 BLISTER PACK (12634-424-67)	7 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-69	12634042469	9 TABLET in 1 BLISTER PACK (12634-424-69)	9 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-71	12634042471	30 TABLET in 1 BOTTLE (12634-424-71)	30 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-74	12634042474	24 TABLET in 1 BOTTLE (12634-424-74)	24 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-78	12634042478	28 TABLET in 1 BOTTLE (12634-424-78)	28 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-79	12634042479	25 TABLET in 1 BOTTLE (12634-424-79)	25 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-80	12634042480	20 TABLET in 1 BOTTLE (12634-424-80)	20 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-81	12634042481	21 TABLET in 1 BOTTLE (12634-424-81)	21 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-82	12634042482	12 TABLET in 1 BOTTLE (12634-424-82)	12 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-84	12634042484	14 TABLET in 1 BOTTLE (12634-424-84)	14 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-85	12634042485	15 TABLET in 1 BOTTLE (12634-424-85)	15 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-90	12634042490	90 TABLET in 1 BOTTLE (12634-424-90)	90 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-91	12634042491	1 TABLET in 1 BLISTER PACK (12634-424-91)	1 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-92	12634042492	2 TABLET in 1 BOTTLE (12634-424-92)	2 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-93	12634042493	3 TABLET in 1 BOTTLE (12634-424-93)	3 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-94	12634042494	4 TABLET in 1 BOTTLE (12634-424-94)	4 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-95	12634042495	5 TABLET in 1 BOTTLE (12634-424-95)	5 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-96	12634042496	6 TABLET in 1 BOTTLE (12634-424-96)	6 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-97	12634042497	7 TABLET in 1 BOTTLE (12634-424-97)	7 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-98	12634042498	8 TABLET in 1 BOTTLE (12634-424-98)	8 tablet	2012-04-30	0000-00-00	No	No	Current
12634-424-99	12634042499	9 TABLET in 1 BOTTLE (12634-424-99)	9 tablet	2012-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine Hydrochloride Tablets USP, 25 mg Rx Only	Apotheca Inc.	2017-01-25	HUMAN PRESCRIPTION DRUG LABEL	1