NDC 49999-763

Ambien CR

Zolpidem Tartrate

Ambien CR is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc. The primary component is Zolpidem Tartrate.

• Product ID: 49999-763_b14add9a-30ab-4cf1-b411-4f46d4ea09e7
• NDC: 49999-763
• Product Type: Human Prescription Drug
• Proprietary Name: Ambien CR
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-12-13
• Marketing Category: NDA / NDA
• Application Number: NDA021774
• Labeler Name: Lake Erie Medical & Surgical Supply DBA Quality Care Products 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49999-763-30

30 TABLET, COATED in 1 BOTTLE (49999-763-30)

• Marketing Start Date: 2011-12-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49999-763-30 [49999076330]

Ambien CR TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021774
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-12-13
• Marketing End Date: 2019-10-11

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	12.5 mg/1

OpenFDA Data

• SPL SET ID: b3e19295-1574-4832-936b-bbf41dfce009
• Manufacturer:
  • Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
• 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