Meclizine Hydrochloride

Product NDC: 82868-058
Requested package NDC: 82868-058-30
11-digit product format: 828680058
Labeler code: 82868
Product ID: 82868-058_56921e73-11c5-90de-e063-6394a90a8882
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA201451
Marketing category: ANDA
Marketing start: 2024-06-11
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201451-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23
A201451-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23
A201451-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201451-001	AA
A201451-002	AA
A201451-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	RS	2011-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA		2011-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	RS	2011-02-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201451-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201451-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201451-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201451-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201451-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201451-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201451-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201451-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201451-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201451-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201451-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201451-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201451-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201451-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201451-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201451-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201451-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201451-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201451-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201451-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201451-001	AA	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Meclizine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MECLIZINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HDP7W44CIO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995666	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1b541252-e8a7-b678-e063-6394a90a34dc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82868-058-20	Meclizine Hydrochloride	20 in 1 BOTTLE, PLASTIC	TABLET	20		3
82868-058-30	Meclizine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82868-058	MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 2 package rows	20240627_1b541252-e8a7-b678-e063-6394a90a34dc.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	1b541252-e8a7-b678-e063-6394a90a34dc	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451 ndc (package): 82868-058-30 ndc (product): 82868-058 ndc11 (package): 82868005830
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Major Pharmaceuticals	f99f13ab-33c0-4304-8dc5-3a75f3909377	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	QPharma Inc	2df6edde-4479-ed9d-e063-6394a90abdc1	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ff719d9c-8d80-42db-97a5-022a75773623	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE	AvPAK	af5d0c9b-a997-8033-afca-3c04221f2e76	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b4716c-411a-62cd-e053-2a95a90a6f4b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	QPharma Inc	18fe5e13-5583-45ee-ab6e-32e9af426bd8	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	American Health Packaging	af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451
Meclizine Hydrochloride	MECLIZINE	Amneal Pharmaceuticals LLC	666dc4d8-7b16-4c3c-84e4-645548dbee68	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201451 application number: ANDA201451

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	1b541252-e8a7-b678-e063-6394a90a34dc	3
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	1b541252-e8a7-b678-e063-6394a90a34dc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82868-058-30	82868005830	30 TABLET in 1 BOTTLE, PLASTIC (82868-058-30)	30 tablet	2024-06-11	No	No	Current