Meclizine Hydrochloride

Product NDC: 62559-842
11-digit product format: 625590842
Labeler code: 62559
Product ID: 62559-842_d6963bdd-88e6-491a-b756-949b51b24d79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA084657
Marketing category: ANDA
Marketing start: 2021-12-27
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62559-842		D	Discontinued by firm	2026-10-05
excluded package	package	62559-842	62559-842-01	D	Discontinued by firm	2026-10-05
excluded package	package	62559-842	62559-842-10	D	Discontinued by firm	2026-10-05

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 1 · 31 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	62559-842-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62559-842-01	`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	62559-842-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62559-842-01	`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	62559-842-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62559-842-01	`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	62559-842-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62559-842-01	`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	62559-842-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62559-842-01	`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	62559-842-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62559-842-01	`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	62559-842-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62559-842-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62559-842-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62559-842-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62559-842-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62559-842-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62559-842-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62559-842-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62559-842-01	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A084657-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982
A084657-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084657-001	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084657-002	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084657-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084657-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084657-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084657-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084657-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A084657-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084657-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084657-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084657-002	AA	1	`782e0a99824c…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084657-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084657-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084657-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084657-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084657-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A084657-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084657-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A084657-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084657-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084657-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084657-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A084657-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084657-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A084657-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084657-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084657-002	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-842-01	EA - Each	62559-842	6379965c-5cdc-4d70-acdf-2fdd13cddedc	1	2022-01-06
62559-842-10	EA - Each	62559-842	f36f9363-14dd-4229-8dc6-f0c10b22e400	1	2022-01-06

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	e6d94c85-4193-2e0e-e053-2a95a90a554a	1
995666	meclizine HCl 25 MG Oral Tablet	PSN	f423e005-c93d-6e51-e053-2995a90a3c2b	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	e6d94c85-4193-2e0e-e053-2a95a90a554a	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	f423e005-c93d-6e51-e053-2995a90a3c2b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-842-01	62559084201	100 TABLET in 1 BOTTLE (62559-842-01)	100 tablet	2021-12-27	0000-00-00	No	No	Current
62559-842-10	62559084210	1000 TABLET in 1 BOTTLE (62559-842-10)	1000 tablet	2021-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-06-04	HUMAN PRESCRIPTION DRUG LABEL	1
Meclizine Hydrochloride	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	102
Meclizine Hydrochloride	Golden State Medical Supply, Inc.	2023-08-22	HUMAN PRESCRIPTION DRUG LABEL	2
Meclizine Hydrochloride	ANI Pharmaceuticals, Inc.	2023-07-26	HUMAN PRESCRIPTION DRUG LABEL	3
Meclizine Hydrochloride	Redpharm Drug, Inc. \| Redpharn Drug, Inc.	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	1
Meclizine Hydrochloride	NuCare Pharmaceuticals,Inc.	2022-09-08	HUMAN PRESCRIPTION DRUG LABEL	2
Meclizine Hydrochloride	NuCare Pharmaceuticals,Inc.	2022-08-22	HUMAN PRESCRIPTION DRUG LABEL	1
Meclizine Hydrochloride	St. Mary's Medical Park Pharmacy	2022-08-02	HUMAN PRESCRIPTION DRUG LABEL	1