Meclizine Hydrochloride

Product NDC

0378-5485

11-digit product format

003785485

Labeler code

0378

Product ID

0378-5485_bf8f38e7-8b67-4646-9a20-5cb24b2bb736

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Meclizine

Dosage form

TABLET

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA202640

Marketing category

ANDA

Marketing start

2012-09-19

Marketing end

2020-01-31

Substance

MECLIZINE HYDROCHLORIDE

Active strength

13 mg/1

Pharmacologic classes

Antiemetic [EPC],Emesis Suppression [PE]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record