NDC 58407-510

ZolpiMIST

Zolpidem Tartrate

ZolpiMIST is a Oral Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Magna Pharmaceuticals, Inc.. The primary component is Zolpidem Tartrate.

• Product ID: 58407-510_91bb9b3f-c212-5738-e053-2995a90a7ec4
• NDC: 58407-510
• Product Type: Human Prescription Drug
• Proprietary Name: ZolpiMIST
• Generic Name: Zolpidem Tartrate
• Dosage Form: Spray, Metered
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-21
• Marketing Category: NDA / NDA
• Application Number: NDA022196
• Labeler Name: Magna Pharmaceuticals, Inc.
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58407-510-60

60 SPRAY, METERED in 1 BOTTLE, PUMP (58407-510-60)

• Marketing Start Date: 2016-03-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58407-510-60 [58407051060]

ZolpiMIST SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-03-21
• Marketing End Date: 2019-10-25

NDC 58407-510-30 [58407051030]

ZolpiMIST SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-03-21
• Marketing End Date: 2019-10-25

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	5 mg/1

OpenFDA Data

• SPL SET ID: b2e26965-30bd-4dca-869d-8a70b23b6d62
• Manufacturer:
  • Magna Pharmaceuticals, Inc.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 828692
  • 828696

Pharmacological Class

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

NDC Crossover Matching brand name "ZolpiMIST" or generic name "Zolpidem Tartrate"

NDC	Brand Name	Generic Name
69654-510	ZOLPIMIST	ZOLPIMIST
58407-510	ZolpiMIST	ZolpiMIST
0024-5401	Ambien	zolpidem tartrate
0024-5421	Ambien	zolpidem tartrate
0024-5501	Ambien	zolpidem tartrate
0024-5521	Ambien	zolpidem tartrate
0037-6010	Edluar	Zolpidem Tartrate
0037-6050	Edluar	Zolpidem Tartrate
0054-0086	Zolpidem Tartrate	zolpidem tartrate
0054-0087	Zolpidem Tartrate	zolpidem tartrate
0093-0073	Zolpidem Tartrate	Zolpidem Tartrate
0093-0074	Zolpidem Tartrate	Zolpidem Tartrate