Meclizine Hydrochloride

Product NDC: 43063-662
11-digit product format: 430630662
Labeler code: 43063
Product ID: 43063-662_9595a664-b780-d726-e053-2995a90a2043
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA202640
Marketing category: ANDA
Marketing start: 2012-09-19
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-662		D	Discontinued by firm	2026-08-17
excluded package	package	43063-662	43063-662-10	D	Discontinued by firm	2026-08-17
excluded package	package	43063-662	43063-662-15	D	Discontinued by firm	2026-08-17
excluded package	package	43063-662	43063-662-30	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-662-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-662-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-662-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-662-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-662-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-662-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-662-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-662-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-662-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-662-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-662-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-662-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-662-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-662-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-662-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-662-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-662-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-662-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-662-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-662-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-662-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-662-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-662-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-662-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-662-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-662-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-662-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-662-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-662-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-662-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-662-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-662-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-662-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-662-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-662-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-662-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-662-10	EA - Each	43063-662	c598e380-cc15-4cd6-a914-8a177cf56d0c	1	2016-10-06
43063-662-15	EA - Each	43063-662	b61d399f-5fa4-4832-8b6b-07e73e98648b	1	2017-04-05
43063-662-30	EA - Each	43063-662	47c9fe21-994b-400d-8e47-738d25322bf6	1	2016-04-04

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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine Hydrochloride - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2019-10-23	HUMAN PRESCRIPTION DRUG LABEL	9