NDC 21695-213

Ambien CR

Zolpidem Tartrate

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

• Product ID: 21695-213_e242ca9c-63bc-44a3-abcf-99632e7703fa
• NDC: 21695-213
• Product Type: Human Prescription Drug
• Proprietary Name: Ambien CR
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA021774
• Labeler Name: Rebel Distributors Corp.
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 13 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 21695-213-30

30 TABLET, COATED in 1 BOTTLE (21695-213-30)

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

NDC SPL Data Element Entries

NDC 21695-213-30 [21695021330]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-30
• Inactivation Date: 2019-09-24

NDC 21695-213-15 [21695021315]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• 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	12.5 mg/1

OpenFDA Data

• SPL SET ID: 968b5154-3c38-4f20-bbeb-495bcb91cc2b
• Manufacturer:
  • Rebel Distributors Corp.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 854894
  • 854882
  • 854896
  • 854880

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 CR" or generic name "Zolpidem Tartrate"

NDC	Brand Name	Generic Name
21695-213	Ambien CR	Ambien CR
21695-319	Ambien CR	Ambien CR
49999-763	Ambien CR	Ambien CR
55289-205	Ambien CR	Ambien CR
63629-3141	Ambien CR	Ambien CR
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