NDC 0024-5521

Ambien CR

Zolpidem Tartrate

Ambien CR is a Oral Tablet, 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: 0024-5521_427f15ee-6b1e-47c2-b358-811e03624670
• NDC: 0024-5521
• Product Type: Human Prescription Drug
• Proprietary Name: Ambien CR
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-09-19
• Marketing Category: NDA / NDA
• Application Number: NDA021774
• Labeler Name: Sanofi-Aventis U.S. LLC
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0024-5521-31

100 TABLET, COATED in 1 BOTTLE (0024-5521-31)

• Marketing Start Date: 2005-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5521-31 [00024552131]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-09-19

NDC 0024-5521-34 [00024552134]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-09-19
• Marketing End Date: 2012-07-10

NDC 0024-5521-10 [00024552110]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-09-19
• Marketing End Date: 2013-06-30

NDC 0024-5521-50 [00024552150]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-09-19
• Marketing End Date: 2013-09-30

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	12.5 mg/1

OpenFDA Data

• SPL SET ID: 404c858c-89ac-4c9d-8a96-8702a28e6e76
• Manufacturer:
  • sanofi-aventis U.S. LLC
• 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