Meclizine Hydrochloride

Product NDC: 52959-225
11-digit product format: 529590225
Labeler code: 52959
Product ID: 52959-225_8602b88e-b064-49c4-a224-11829d706003
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: meclizine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA087127
Marketing category: ANDA
Marketing start: 1981-06-03
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 13 mg/1
Pharmacologic classes: Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-225		I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-00	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-07	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-12	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-20	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-21	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-30	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-60	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-225	52959-225-90	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 4 · 198 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	52959-225-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-225-30	`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	52959-225-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-225-30	`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	52959-225-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-225-30	`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	52959-225-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-225-30	`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	52959-225-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-225-30	`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	52959-225-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-225-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-225-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-225-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-225-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-225-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-225-21	`302b2466d912…`	`e7b80fea0513…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087127-001	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A087127-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087127-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087127-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087127-001	AA	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-225-00	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-07	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-12	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-20	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-21	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-30	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-60	480076cf-3fc6-4752-985a-9e20f725723e
52959-225-90	480076cf-3fc6-4752-985a-9e20f725723e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-225-00	Meclizine Hydrochloride	100 in 1 BOTTLE	TABLET	100	2
52959-225-07	Meclizine Hydrochloride	7 in 1 BOTTLE	TABLET	7	2
52959-225-12	Meclizine Hydrochloride	12 in 1 BOTTLE	TABLET	12	2
52959-225-20	Meclizine Hydrochloride	20 in 1 BOTTLE	TABLET	20	2
52959-225-21	Meclizine Hydrochloride	21 in 1 BOTTLE	TABLET	21	2
52959-225-30	Meclizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	2
52959-225-60	Meclizine Hydrochloride	60 in 1 BOTTLE	TABLET	60	2
52959-225-90	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
52959-225-00	EA - Each	52959-225	08c44597-6424-407f-9aeb-c9441f068cd5	1	2012-07-24
52959-225-07	EA - Each	52959-225	51cd2cba-4e41-45f5-9a74-5595e8856c78	1	2012-07-24
52959-225-12	EA - Each	52959-225	c23c127f-e41b-4c80-b050-faeadcf2ef7d	1	2012-07-24
52959-225-20	EA - Each	52959-225	7ecc3221-fdc2-4dee-a6c6-f1d6fae3b5d5	1	2012-07-24
52959-225-21	EA - Each	52959-225	26677eda-d145-49cf-a730-da4316eb3ad2	1	2012-07-24
52959-225-30	EA - Each	52959-225	fb6840e7-2c5d-4741-a9d9-cce7e9cbd078	1	2012-07-24
52959-225-60	EA - Each	52959-225	df6a6b7d-cd11-4c3e-afcb-5a3c3cbcedd1	1	2012-07-24
52959-225-90	EA - Each	52959-225	b26e82ad-f25a-45ff-a316-ea4c1f56446a	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 TABLET [H.J. HARKINS COMPANY, INC.]	2
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MECLIZINE HYDROCHLORIDE 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
52959-225	MECLIZINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 8 package rows	20120120_480076cf-3fc6-4752-985a-9e20f725723e.zip

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
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	480076cf-3fc6-4752-985a-9e20f725723e	2
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	480076cf-3fc6-4752-985a-9e20f725723e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-225-00	52959022500	100 in 1 BOTTLE	Historical
52959-225-07	52959022507	7 in 1 BOTTLE	Historical
52959-225-12	52959022512	12 in 1 BOTTLE	Historical
52959-225-20	52959022520	20 in 1 BOTTLE	Historical
52959-225-21	52959022521	21 in 1 BOTTLE	Historical
52959-225-30	52959022530	30 in 1 BOTTLE	Historical
52959-225-60	52959022560	60 in 1 BOTTLE	Historical
52959-225-90	52959022590	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine Hydrochloride - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	2