NDC 69654-510

ZOLPIMIST

Zolpidem Tartrate

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

• Product ID: 69654-510_4c487110-fe30-4b65-a49b-cc5aff52e045
• NDC: 69654-510
• Product Type: Human Prescription Drug
• Proprietary Name: ZOLPIMIST
• Generic Name: Zolpidem Tartrate
• Dosage Form: Spray, Metered
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-26
• Marketing Category: NDA / NDA
• Application Number: NDA022196
• Labeler Name: Aytu BioScience, 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 69654-510-30

1 BOTTLE, SPRAY in 1 CARTON (69654-510-30) > 30 SPRAY, METERED in 1 BOTTLE, SPRAY

• Marketing Start Date: 2019-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69654-510-60 [69654051060]

ZOLPIMIST SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-26

NDC 69654-510-30 [69654051030]

ZOLPIMIST SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA022196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-26

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	5 mg/1

OpenFDA Data

• SPL SET ID: 7b99e2ac-ff5b-c07a-e053-2a91aa0a6ade
• Manufacturer:
  • Aytu BioScience, Inc.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 828692
  • 828696
• UPC Code:
  • 0369654510304
  • 0369654510601

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