NDC 21695-212

Ambien

Zolpidem Tartrate

Ambien is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Zolpidem Tartrate.

• Product ID: 21695-212_c298d925-bf40-442d-9041-dea5c50fb60b
• NDC: 21695-212
• Product Type: Human Prescription Drug
• Proprietary Name: Ambien
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA019908
• Labeler Name: Rebel Distributors Corp.
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-212-45

45 TABLET, FILM COATED in 1 BOTTLE (21695-212-45)

• Marketing Start Date: 2009-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-212-30 [21695021230]

Ambien TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA019908
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-30
• Inactivation Date: 2019-09-24

NDC 21695-212-45 [21695021245]

Ambien TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA019908
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-30
• Inactivation Date: 2019-09-24

NDC 21695-212-15 [21695021215]

Ambien TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA019908
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-30
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	10 mg/1

OpenFDA Data

• SPL SET ID: 9dea009e-d435-4268-ab25-cf48a6c69abb
• Manufacturer:
  • Rebel Distributors Corp.
• 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