MECLIZINE HYDROCHLORIDE

Product NDC: 50090-7417
11-digit product format: 500907417
Labeler code: 50090
Product ID: 50090-7417_129bad2d-36ae-482f-a8b0-a574d738216c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MECLIZINE
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202640
Marketing category: ANDA
Marketing start: 2023-09-14
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202640-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17
A202640-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17
A202640-003	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202640-001	AA
A202640-002	AA
A202640-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A202640-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202640-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202640-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202640-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202640-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202640-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202640-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202640-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202640-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202640-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202640-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202640-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202640-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202640-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202640-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202640-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202640-001	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
55e262d9-d9dd-43a3-bc74-35e46dd391be	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
50090-7417-0	MECLIZINE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET	20	2
50090-7417-1	MECLIZINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	2
50090-7417-4	MECLIZINE HYDROCHLORIDE	10 in 1 BOTTLE	TABLET	10	2
50090-7417-8	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
50090-7417-0	EA - Each	50090-7417	b5bd1434-a56c-48a0-af74-b05e4065d600	1	2024-12-10
50090-7417-1	EA - Each	50090-7417	c293e518-beb7-45d5-b5ee-5ade5d7a4ad7	1	2024-12-10
50090-7417-4	EA - Each	50090-7417	c8e7c16c-2768-4306-8aa8-e22ebebbece4	1	2024-12-10
50090-7417-8	EA - Each	50090-7417	7a432117-7b93-434a-aa5f-e035fdfd9ab2	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7417	MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [A-S MEDICATION SOLUTIONS]	2	Current NDC, 4 package rows	20241031_55e262d9-d9dd-43a3-bc74-35e46dd391be.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	Preferred Pharmaceuticals Inc.	f755f8f3-7645-433c-b502-c1f15b700299	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Bryant Ranch Prepack	dab43efd-bec6-472f-b13a-1c043914dcd1	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Bryant Ranch Prepack	1079db3f-d8ad-4c25-aa91-8ac8054ee4f2	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Redpharm Drug	52ee9258-8311-e6bd-e063-6294a90a567f	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Redpharm Drug	4727e7a9-eabb-a2a7-e063-6394a90a8754	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	A-S Medication Solutions	55e262d9-d9dd-43a3-bc74-35e46dd391be	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640 ndc (product): 50090-7417
MECLIZINE HYDROCHLORIDE	MECLIZINE	A-S Medication Solutions	949f7347-8c3a-43ce-b975-8d187096f09f	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	NCS HealthCare of KY, LLC dba Vangard Labs	1a33dec1-8d59-48bd-aaef-77d162194d57	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640
MECLIZINE HYDROCHLORIDE	MECLIZINE	Aurobindo Pharma Limited	beb3c7f2-c0f4-41d9-a903-63a6847e0997	2023-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202640 application number: ANDA202640

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE
3L5TQ84570	MECLIZINE	569-65-3	MECLIZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995666	meclizine HCl 25 MG Oral Tablet	PSN	55e262d9-d9dd-43a3-bc74-35e46dd391be	2
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	55e262d9-d9dd-43a3-bc74-35e46dd391be	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7417-0	50090741700	20 TABLET in 1 BOTTLE (50090-7417-0)	20 tablet	2024-10-28	No	No	Current
50090-7417-1	50090741701	30 TABLET in 1 BOTTLE (50090-7417-1)	30 tablet	2024-10-28	No	No	Current
50090-7417-4	50090741704	10 TABLET in 1 BOTTLE (50090-7417-4)	10 tablet	2024-10-28	No	No	Current
50090-7417-8	50090741708	90 TABLET in 1 BOTTLE (50090-7417-8)	90 tablet	2024-10-28	No	No	Current