ZolpiMIST

Product NDC

58407-510

11-digit product format

584070510

Labeler code

58407

Product ID

58407-510_91bb9b3f-c212-5738-e053-2995a90a7ec4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Zolpidem Tartrate

Dosage form

SPRAY, METERED

Route

ORAL

Labeler

Magna Pharmaceuticals, Inc.

Application

NDA022196

Marketing category

NDA

Marketing start

2016-03-21

Marketing end

0000-00-00

Substance

ZOLPIDEM TARTRATE

Active strength

5 mg/1

Pharmacologic classes

gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]

DEA schedule

CIV

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record