Meclizine Hydrochloride

Product NDC: 68071-3748
11-digit product format: 680713748
Labeler code: 68071
Product ID: 68071-3748_352f1797-e850-efb9-e063-6294a90a6442
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA213957
Marketing category: ANDA
Marketing start: 2020-10-29
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213957-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA		2020-06-23
A213957-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2020-06-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213957-001	AA
A213957-002	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 2 · 74 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	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2020-06-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2020-06-23	`87673890dc5c…`

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
2026-02-19 14:30 UTC	2026-02	A213957-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213957-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213957-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213957-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213957-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213957-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213957-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213957-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213957-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213957-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213957-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213957-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213957-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213957-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213957-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213957-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213957-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213957-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213957-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213957-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213957-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213957-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213957-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213957-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213957-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213957-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213957-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213957-002	AA	1	`87673890dc5c…`

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
2990e296-2d60-70c0-e063-6394a90abbe4	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
68071-3748-4	Meclizine Hydrochloride	4 in 1 BOTTLE	TABLET	4		2
68071-3748-6	Meclizine Hydrochloride	6 in 1 BOTTLE	TABLET	6		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3748	MECLIZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20250516_2990e296-2d60-70c0-e063-6394a90abbe4.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Redpharm Drug	53df5b1b-64da-e805-e063-6294a90a0a55	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Redpharm Drug	37457bd5-2fdd-b829-e063-6294a90a04f0	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2990e296-2d60-70c0-e063-6394a90abbe4	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957 ndc (product): 68071-3748
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2e0ed1fc-53e6-a3b1-e063-6394a90af419	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	947a03c5-bca0-4d97-90b9-bcd6d6588273	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	eae4bc73-fee1-4831-b31c-8ca56fb83ad7	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Zydus Lifesciences Limited	cf157a71-f80a-4fb7-b892-7102b65a8ec0	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	51c96c7a-0a38-41a5-a6c9-7f45db65fdda	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213957 application number: ANDA213957

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	2990e296-2d60-70c0-e063-6394a90abbe4	2
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	2990e296-2d60-70c0-e063-6394a90abbe4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3748-4	68071374804	4 TABLET in 1 BOTTLE (68071-3748-4)	4 tablet	2025-05-15	No	No	Current
68071-3748-6	68071374806	6 TABLET in 1 BOTTLE (68071-3748-6)	6 tablet	2024-12-18	No	No	Current