NDC 0024-5421

Ambien

Zolpidem Tartrate

Ambien is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Zolpidem Tartrate.

• Product ID: 0024-5421_4a9a3374-79ea-4b4c-b4b9-21e0e60e1b82
• NDC: 0024-5421
• Product Type: Human Prescription Drug
• Proprietary Name: Ambien
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1993-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA019908
• Labeler Name: Sanofi-Aventis U.S. LLC
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 10 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 0024-5421-31

100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)

• Marketing Start Date: 1993-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5421-50 [00024542150]

Ambien TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA019908
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1993-04-01
• Marketing End Date: 2016-03-31

NDC 0024-5421-34 [00024542134]

Ambien TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA019908
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1993-04-01
• Marketing End Date: 2012-06-19

NDC 0024-5421-31 [00024542131]

Ambien TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA019908
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1993-04-01

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	10 mg/1

OpenFDA Data

• SPL SET ID: c36cadf4-65a4-4466-b409-c82020b42452
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 854873
  • 854878
  • 854876
  • 854875

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0024-5401	Ambien	zolpidem tartrate
0024-5421	Ambien	zolpidem tartrate
0024-5501	Ambien	zolpidem tartrate
0024-5521	Ambien	zolpidem tartrate
21695-212	Ambien	Ambien
21695-211	Ambien	Ambien
61919-948	AMBIEN	AMBIEN
61919-803	AMBIEN	AMBIEN
80425-0087	Ambien	Ambien
80425-0060	Ambien	Ambien
80425-0061	Ambien	Ambien
80425-0059	Ambien	Ambien
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