Meclizine Hydrochloride

Product NDC: 50436-0014
11-digit product format: 504360014
Labeler code: 50436
Product ID: 50436-0014_ab189210-7a46-4cd6-bf2b-e456f351bae4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA200294
Marketing category: ANDA
Marketing start: 2012-04-30
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-0014		I	Inactivated by FDA	2026-08-17
excluded package	package	50436-0014	50436-0014-1	I	Inactivated by FDA	2026-08-17
excluded package	package	50436-0014	50436-0014-3	I	Inactivated by FDA	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 · 57 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	50436-0014-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0014-1	`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	50436-0014-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0014-1	`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	50436-0014-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0014-1	`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	50436-0014-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0014-1	`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	50436-0014-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0014-1	`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	50436-0014-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0014-1	`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	50436-0014-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0014-1	`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	50436-0014-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-0014-1	`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	50436-0014-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-0014-1	`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	50436-0014-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-0014-1	`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	50436-0014-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-0014-1	`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	50436-0014-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-0014-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-0014-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-0014-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-0014-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-0014-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-0014-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-0014-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-0014-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-0014-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-0014-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-0014-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-0014-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-0014-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-0014-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-0014-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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

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
A200294-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA		2012-04-13
A200294-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2012-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200294-001	AA
A200294-002	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 3 · 84 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	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200294-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2012-04-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200294-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-04-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A200294-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200294-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200294-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200294-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200294-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200294-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200294-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200294-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200294-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200294-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200294-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200294-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200294-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200294-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200294-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200294-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200294-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200294-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200294-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200294-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200294-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200294-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200294-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200294-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200294-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200294-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200294-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200294-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200294-002	AA	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0014-1	2021-01-29	C162847	48780-1	ba0f9c33-22bb-a910-e053-dadaa90a0b85	Meclizine Hydrochloride Tablets USP, 12.5 mg and 25 mg Rx Only
50436-0014-3	2021-01-29	C162847	48780-1	ba0f9c33-22bb-a910-e053-dadaa90a0b85	Meclizine Hydrochloride Tablets USP, 12.5 mg and 25 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0014-1	Meclizine Hydrochloride	30 in 1 BOTTLE	TABLET	30		2
50436-0014-3	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
50436-0014-1	EA - Each	50436-0014	bea582f7-67a0-4b34-a45d-f50e038fc0e2	1	2017-11-06
50436-0014-3	EA - Each	50436-0014	4f7fd79f-15bb-46b1-9f5c-dca4728b34da	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0014	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2	Legacy NDC, 2 package rows	20171012_b9ab298e-b7d7-44ab-a0eb-7fcbe3ea2157.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	91b1fd1a-1da2-4aae-826f-7de0bfe62161	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200294 application number: ANDA200294
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Epic Pharma LLC	467e464b-bbaf-4053-9136-39e47a92fa05	2020-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200294 application number: ANDA200294

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	b9ab298e-b7d7-44ab-a0eb-7fcbe3ea2157	2
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	b9ab298e-b7d7-44ab-a0eb-7fcbe3ea2157	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0014-1	50436001401	30 in 1 BOTTLE	Historical
50436-0014-3	50436001403	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meclizine Hydrochloride Tablets USP, 12.5 mg and 25 mg Rx Only	Unit Dose Services	2017-10-12	HUMAN PRESCRIPTION DRUG LABEL	2