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 1 of 5 · 88 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	Name fallback brand name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	Bryant Ranch Prepack	dab43efd-bec6-472f-b13a-1c043914dcd1	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rugby Laboratories	b57f14a7-3852-03db-e053-2a95a90a80d6	2026-07-16	Warnings	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	1b541252-e8a7-b678-e063-6394a90a34dc	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	REMEDYREPACK INC.	ba2fb6de-af86-4c05-9018-135e1f8594f9	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b11c10b9-f40e-4ea7-9c5d-118517049f9d	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
DRAMAMINE CHEWABLE ORANGE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	30387e63-278d-412a-bcad-7965c7c0aea7	2026-06-23	Warnings	Name fallback generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	c6b3f4d8-5fcf-2278-e053-2a95a90ab139	2026-06-21	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d7d31433-8f39-4fe6-b542-1b4410122db7	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Redpharm Drug	53df5b1b-64da-e805-e063-6294a90a0a55	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	Bryant Ranch Prepack	1079db3f-d8ad-4c25-aa91-8ac8054ee4f2	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE	MECLIZINE	Redpharm Drug	52ee9258-8311-e6bd-e063-6294a90a567f	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	81e1762b-e012-4c6d-96e6-9a9f27a1880a	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Major Pharmaceuticals	f99f13ab-33c0-4304-8dc5-3a75f3909377	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	REMEDYREPACK INC.	21d4a6ee-0a66-45d7-bab9-c5eef399713d	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	QPharma Inc	2df6edde-4479-ed9d-e063-6394a90abdc1	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
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	REMEDYREPACK INC.	d53bf04e-5cfc-4974-9b24-2cce545d1bd0	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Meclizine Hydrochloride generic 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

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