MECLIZINE HYDROCHLORIDE

Product NDC: 71335-3141
11-digit product format: 713353141
Labeler code: 71335
Product ID: 71335-3141_6c523373-60b5-436e-8e78-10e9bb9c997a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MECLIZINE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202640
Marketing category: ANDA
Marketing start: 2023-09-14
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 12.5 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	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 · 129 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
2026-09-14 22:38:34	2026-08	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202640-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-003	MECLIZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-09-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A202640-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202640-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202640-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202640-003	AA	1	`caaa826d4ba7…`
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…`

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	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
1079db3f-d8ad-4c25-aa91-8ac8054ee4f2	Available on FDA.report

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 ndc (product): 71335-3141
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3141-1	71335314101	30 TABLET in 1 BOTTLE (71335-3141-1)	30 tablet	2026-06-08	No	No	Current
71335-3141-2	71335314102	60 TABLET in 1 BOTTLE (71335-3141-2)	60 tablet	2026-06-08	No	No	Current
71335-3141-3	71335314103	90 TABLET in 1 BOTTLE (71335-3141-3)	90 tablet	2026-06-08	No	No	Current
71335-3141-4	71335314104	28 TABLET in 1 BOTTLE (71335-3141-4)	28 tablet	2026-06-08	No	No	Current
71335-3141-5	71335314105	20 TABLET in 1 BOTTLE (71335-3141-5)	20 tablet	2026-06-08	No	No	Current
71335-3141-6	71335314106	120 TABLET in 1 BOTTLE (71335-3141-6)	120 tablet	2026-06-08	No	No	Current
71335-3141-7	71335314107	100 TABLET in 1 BOTTLE (71335-3141-7)	100 tablet	2026-06-08	No	No	Current
71335-3141-8	71335314108	10 TABLET in 1 BOTTLE (71335-3141-8)	10 tablet	2026-06-08	No	No	Current