MECLIZINE HYDROCHLORIDE

Product NDC: 52959-033
11-digit product format: 529590033
Labeler code: 52959
Product ID: 52959-033_dda3a80a-8f5f-4502-ac2c-d4ac81fab9ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrocloride
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA040659
Marketing category: ANDA
Marketing start: 2010-06-04
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-033		I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-00	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-04	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-10	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-15	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-20	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-21	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-25	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-30	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-60	I	Inactivated by FDA	2026-09-09
excluded package	package	52959-033	52959-033-90	I	Inactivated by FDA	2026-09-09

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 5 · 242 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	52959-033-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-033-00	`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	52959-033-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-033-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-033-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-033-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-033-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-033-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-033-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-033-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-033-60	`cdf11ea48f46…`	`ba0047e9e063…`

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
A040659-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA		2010-06-04
A040659-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2010-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040659-001	AA
A040659-002	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	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`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	A040659-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040659-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040659-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040659-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040659-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040659-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040659-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040659-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040659-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040659-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040659-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040659-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040659-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040659-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040659-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040659-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040659-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040659-002	AA	1	`bb7c543d1eb4…`

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
52959-033-00	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-04	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-10	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-15	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-20	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-21	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-25	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-30	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-60	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
52959-033-90	MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-033-00	MECLIZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100	2
52959-033-04	MECLIZINE HYDROCHLORIDE	4 in 1 BOTTLE	TABLET	4	2
52959-033-10	MECLIZINE HYDROCHLORIDE	10 in 1 BOTTLE	TABLET	10	2
52959-033-15	MECLIZINE HYDROCHLORIDE	15 in 1 BOTTLE	TABLET	15	2
52959-033-20	MECLIZINE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET	20	2
52959-033-21	MECLIZINE HYDROCHLORIDE	21 in 1 BOTTLE	TABLET	21	2
52959-033-25	MECLIZINE HYDROCHLORIDE	25 in 1 BOTTLE	TABLET	25	2
52959-033-30	MECLIZINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	2
52959-033-60	MECLIZINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	2
52959-033-90	MECLIZINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-033-00	EA - Each	52959-033	69738f1d-d1c8-49d9-ae91-7ca9ea87e7cc	1	2012-07-24
52959-033-04	EA - Each	52959-033	c677993d-28a5-4934-b3c8-a2fa2c136181	1	2012-07-24
52959-033-10	EA - Each	52959-033	daa487ec-b47b-480d-824c-2253cddc0dc5	1	2012-07-24
52959-033-20	EA - Each	52959-033	6af39fb1-d5ee-402b-90be-b46ddc2d2402	1	2012-07-24
52959-033-21	EA - Each	52959-033	0c1eb391-e0cd-49e1-a6dc-f15b21c89de7	1	2012-07-24
52959-033-25	EA - Each	52959-033	7baa22a9-38c9-4f95-8703-d12a7211756a	1	2012-07-24
52959-033-30	EA - Each	52959-033	b60c73d5-f612-4b4b-8b11-094ed6ff81f2	1	2012-07-24
52959-033-60	EA - Each	52959-033	229e3a36-fdcd-4043-af59-5d69da8a8333	1	2012-07-24
52959-033-90	EA - Each	52959-033	77e7ad0f-ca38-4552-bfb7-d889440fc84d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Meclizine Hydrochloride	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Meclizine	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-033	MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 10 package rows	20120217_180aedec-8a48-4e56-8eed-7daff874161b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	REMEDYREPACK INC.	ba2fb6de-af86-4c05-9018-135e1f8594f9	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	c443873a-2e89-43b2-b145-dde3dadf7bc0	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
Meclizine Hydrocloride	MECLIZINE HYDROCLORIDE	QPharma Inc	aa0fb895-a867-4482-9bc2-16eee8bfaaa0	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	522b55a2-313c-45e8-b1be-07746ada5b0a	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Bryant Ranch Prepack	f43bf077-3f29-48ec-8ca8-eb294dbf2001	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6dd657ba-46dc-4106-9f6a-dfa0ecf85752	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6c66ee38-10bb-4559-9d2f-51e6d6f091ee	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Jubilant Cadista Pharmacuticals Inc.	9350fefc-9c00-182c-c3a9-044d4a40856f	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	NuCare Pharmaceuticals,Inc.	64a508ae-768a-2fba-e053-2991aa0ac42d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	6a8cbc12-0725-4462-bb71-0b18cefc19e7	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Proficient Rx LP	f574e123-8db7-4e3d-a0ee-e4e1f04ff146	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Asclemed USA, Inc.	5c70e61b-a1e6-4981-92e2-1050cee08baa	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	53f410fd-104c-42c1-9740-6f48ffbc974f	2020-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659

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	180aedec-8a48-4e56-8eed-7daff874161b	2
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	180aedec-8a48-4e56-8eed-7daff874161b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-033-00	52959003300	100 in 1 BOTTLE	Historical
52959-033-04	52959003304	4 in 1 BOTTLE	Historical
52959-033-10	52959003310	10 in 1 BOTTLE	Historical
52959-033-15	52959003315	15 in 1 BOTTLE	Historical
52959-033-20	52959003320	20 in 1 BOTTLE	Historical
52959-033-21	52959003321	21 in 1 BOTTLE	Historical
52959-033-25	52959003325	25 in 1 BOTTLE	Historical
52959-033-30	52959003330	30 in 1 BOTTLE	Historical
52959-033-60	52959003360	60 in 1 BOTTLE	Historical
52959-033-90	52959003390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only	H.J. Harkins Company, Inc. \| JUBILANT CADISTA PHARMACEUTICALS, INC.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL	2