NDC 55289-205

Ambien CR

Zolpidem Tartrate

Ambien CR is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Zolpidem Tartra.

• Product ID: 55289-205_776db34b-4fda-4944-e053-2a91aa0a1ecb
• NDC: 55289-205
• 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: PD-Rx Pharmaceuticals, In
• Substance Name: ZOLPIDEM TARTRA
• Active Ingredient Strength: 13 mg/1
• Pharm Classes: gamma-Aminobuty
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-205-30

30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-205-30)

• Marketing Start Date: 2010-10-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-205-30 [55289020530]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-10-13

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	12.5 mg/1

OpenFDA Data

• SPL SET ID: fa181279-dce7-4a3f-aba8-b9c2806fdd34
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 854882
  • 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