Meclizine Hydrochloride

Product NDC: 71205-647
11-digit product format: 712050647
Labeler code: 71205
Product ID: 71205-647_bf1db485-1415-4229-b3e1-05a6f62ff7dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: NDA010721
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-01-15
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 12.5 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N010721-001	ANTIVERT	MECLIZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, RS	1982-01-20
N010721-004	ANTIVERT	MECLIZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982
N010721-005	ANTIVERT	MECLIZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, RS, Approved before 1982
N010721-006	ANTIVERT	MECLIZINE HYDROCHLORIDE	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD, Approved before 1982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.

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
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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		`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N010721-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N010721-004	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N010721-006	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (product): 71205-647
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

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	12.5 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
995624	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
92e8390b-5173-4aa1-906d-35d2c0eaaaf6	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	Strength	SPL version
71205-647-10	Meclizine Hydrochloride	10 in 1 BOTTLE	TABLET	10		2
71205-647-90	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
71205-647-10	EA - Each	71205-647	cc7f4b07-0b20-49a3-9b01-47fc0b605948	1	2022-06-06
71205-647-90	EA - Each	71205-647	938066e2-2cd3-40c2-9bd5-a4006206807a	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-647	MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 2 package rows	20240822_92e8390b-5173-4aa1-906d-35d2c0eaaaf6.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	92e8390b-5173-4aa1-906d-35d2c0eaaaf6	2
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	92e8390b-5173-4aa1-906d-35d2c0eaaaf6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-647-10	71205064710	10 TABLET in 1 BOTTLE (71205-647-10)	10 tablet	2022-03-23	0000-00-00	No	No	Current
71205-647-20	71205064720	20 TABLET in 1 BOTTLE (71205-647-20)	20 tablet	2022-03-23	0000-00-00	No	No	Current
71205-647-30	71205064730	30 TABLET in 1 BOTTLE (71205-647-30)	30 tablet	2022-03-23	0000-00-00	No	No	Current
71205-647-60	71205064760	60 TABLET in 1 BOTTLE (71205-647-60)	60 tablet	2022-03-23	0000-00-00	No	No	Current
71205-647-90	71205064790	90 TABLET in 1 BOTTLE (71205-647-90)	90 tablet	2022-03-23	0000-00-00	No	No	Current