Application 087127

Type: ANDA
Sponsor: AUREX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087127-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A087127-001	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A087127-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087127-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087127-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087127-001	AA	1	`ea99ee380514…`

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 3 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Motion Sickness Relief	MECLIZINE HYDROCHLORIDE	TARGET CORPORATION	36ba2950-4a09-e5de-e063-6394a90a1771	2025-09-04	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6c66ee38-10bb-4559-9d2f-51e6d6f091ee	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	112103bc-25e2-42cf-8542-ba1d3392a2c3	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	27b6a7e0-a361-4705-9f31-719063a65f22	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Jubilant Cadista Pharmacuticals Inc.	9350fefc-9c00-182c-c3a9-044d4a40856f	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	American Health Packaging	af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2990e296-2d60-70c0-e063-6394a90abbe4	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
BONINE MAX	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	7326a47e-284e-4b6f-8eb0-7933dc1e3f0d	2025-04-11	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
BONINE	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	2025-03-21	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
BONINE	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	0b2ea6b8-b342-4940-8922-898758fbeb31	2025-03-21	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Chartwell RX, LLC	87d4c6d8-9218-48c2-9163-615a32449f11	2025-03-14	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Walgreen Company	ecf8d05e-0e77-f3e8-e053-2a95a90a6604	2025-03-11	Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2e0ed1fc-53e6-a3b1-e063-6394a90af419	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2d31ae73-3f09-a77c-e063-6294a90ade9a	2025-02-02	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	DirectRx	d27fe828-4fee-3ba9-e053-2995a90ae7b6	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	e4d785a7-a688-3acb-e053-2a95a90a6d2e	2025-01-09	Boxed warning, Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	ed43bf21-f3da-245c-e053-2995a90a504c	2025-01-09	Boxed warning, Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine	MECLIZINE HYDROCHLORIDE	Advanced Rx LLC	b0a2a1f7-354e-48bd-9e98-9207bf9f53fd	2024-11-27	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine HCl	MECLIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	acdf636c-66f1-4a1f-87a8-786f51d75708	2024-11-13	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1553	Meclizine Hydrochloride	meclizine hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
21695-383	Meclizine Hydrochloride	Meclizine Hydrochloride	Rebel Distributors Corp.	ANDA	Current
49884-034	Meclizine Hydrochloride	meclizine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-034	Meclizine Hydrochloride	meclizine hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
52959-225	Meclizine Hydrochloride	meclizine hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
60429-204	Meclizine Hydrochloride	meclizine hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current