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 2 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE	Redpharm Drug	4727e7a9-eabb-a2a7-e063-6394a90a8754	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c31846b2-d47d-a97b-e053-2a95a90a9bec	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	beb36d86-9fb7-1f60-e053-2995a90aac13	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ff719d9c-8d80-42db-97a5-022a75773623	2026-03-01	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Dramamine Less Drowsy	MECLIZINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	4b203479-ba8d-7237-e063-6294a90ae6cb	2026-02-18	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-8fe9-8776-e053-2a95a90ae651	2026-01-27	Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	c443873a-2e89-43b2-b145-dde3dadf7bc0	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE	AvPAK	af5d0c9b-a997-8033-afca-3c04221f2e76	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b4716c-411a-62cd-e053-2a95a90a6f4b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
CVS Motion Sickness Fast Melting	MECLIZINE HYDROCHLORIDE	CVS Pharmacy, Inc.	2a723bce-a581-4558-b028-22f1f9125dd5	2025-12-30	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Wal-Dram 2 Quick-Dissolving	MECLIZINE HYDROCHLORIDE	Walgreen Co.	f3116203-1b8f-438a-b779-7bdd90eaf79e	2025-12-30	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Redpharm Drug	37457bd5-2fdd-b829-e063-6294a90a04f0	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	fdcbcc4e-9370-4975-8905-1f12c73fdc8c	2025-12-23	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	3a960d43-62aa-464e-92b9-d83042ba02bf	2025-12-23	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	6efd3473-ee14-4ee0-8a58-d15a64a9224a	2025-12-18	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	QPharma Inc	18fe5e13-5583-45ee-ab6e-32e9af426bd8	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	522b55a2-313c-45e8-b1be-07746ada5b0a	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	CVS Pharmacy, Inc	b57fc6c2-fbfc-24c3-e053-2995a90a3389	2025-10-16	Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Bryant Ranch Prepack	f43bf077-3f29-48ec-8ca8-eb294dbf2001	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6dd657ba-46dc-4106-9f6a-dfa0ecf85752	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE 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