Meclizine Hydrochloride

Product NDC: 80425-0494
11-digit product format: 804250494
Labeler code: 80425
Product ID: 80425-0494_2d31baa5-5e96-61fa-e063-6394a90a7413
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: NDA010721
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-02-02
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N010721-001	ANTIVERT	MECLIZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20
N010721-004	ANTIVERT	MECLIZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982
N010721-005	ANTIVERT	MECLIZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982
N010721-006	ANTIVERT	MECLIZINE HYDROCHLORIDE	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N010721-001	AA
N010721-004	AA
N010721-006	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010721-001	ANTIVERT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010721-004	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010721-005	ANTIVERT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010721-006	ANTIVERT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982		`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 149 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	N010721-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010721-004	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010721-006	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-004	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010721-006	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010721-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010721-004	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010721-006	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-004	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010721-006	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-004	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010721-006	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-004	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010721-006	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-004	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010721-006	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-004	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010721-006	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-004	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010721-006	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010721-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010721-004	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010721-006	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010721-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010721-004	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010721-006	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010721-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010721-004	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010721-006	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010721-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010721-004	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010721-006	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010721-001	AA	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Meclizine Hydrochloride
Listing expiration: 2026-12-31

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
2d31ae73-3f09-a77c-e063-6294a90ade9a	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0494-1	Meclizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	1
80425-0494-2	Meclizine Hydrochloride	60 in 1 BOTTLE	TABLET	60	1
80425-0494-3	Meclizine Hydrochloride	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0494-1	EA - Each	80425-0494	136b1cfe-6b9a-4575-ad52-3dc754d4b79e	1	2025-03-04
80425-0494-2	EA - Each	80425-0494	c7014f6b-dbea-4409-80b9-b08cfcb407ef	1	2025-03-04
80425-0494-3	EA - Each	80425-0494	105c9b1a-21dc-4e1e-b082-5b28915344c0	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0494	MECLIZINE HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 3 package rows	20250204_2d31ae73-3f09-a77c-e063-6294a90ade9a.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	c6b3f4d8-5fcf-2278-e053-2a95a90ab139	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d7d31433-8f39-4fe6-b542-1b4410122db7	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	81e1762b-e012-4c6d-96e6-9a9f27a1880a	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	REMEDYREPACK INC.	21d4a6ee-0a66-45d7-bab9-c5eef399713d	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	REMEDYREPACK INC.	d53bf04e-5cfc-4974-9b24-2cce545d1bd0	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c31846b2-d47d-a97b-e053-2a95a90a9bec	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	beb36d86-9fb7-1f60-e053-2995a90aac13	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	112103bc-25e2-42cf-8542-ba1d3392a2c3	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	27b6a7e0-a361-4705-9f31-719063a65f22	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2d31ae73-3f09-a77c-e063-6294a90ade9a	2025-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721 ndc (product): 80425-0494
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	DirectRx	d27fe828-4fee-3ba9-e053-2995a90ae7b6	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	92e8390b-5173-4aa1-906d-35d2c0eaaaf6	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Direct_Rx	e79ecf77-0e0a-d7ef-e053-2a95a90a5adf	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Asclemed USA, Inc.	e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	b91435d1-fb95-4939-8478-84e41f44f732	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010721 application number: NDA010721

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	2d31ae73-3f09-a77c-e063-6294a90ade9a	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	2d31ae73-3f09-a77c-e063-6294a90ade9a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0494-1	80425049401	30 TABLET in 1 BOTTLE (80425-0494-1)	30 tablet	2025-02-02	No	No	Current
80425-0494-2	80425049402	60 TABLET in 1 BOTTLE (80425-0494-2)	60 tablet	2025-02-02	No	No	Current
80425-0494-3	80425049403	90 TABLET in 1 BOTTLE (80425-0494-3)	90 tablet	2025-02-02	No	No	Current