NDC 0228-3481

Zolpidem Tartrate

Zolpidem Tartrate

Zolpidem Tartrate is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Zolpidem Tartrate.

• Product ID: 0228-3481_018077ff-d4f5-4be3-9a8e-3061ab1fe026
• NDC: 0228-3481
• Product Type: Human Prescription Drug
• Proprietary Name: Zolpidem Tartrate
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-10-14
• Marketing End Date: 2019-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078179
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 6 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

Packaging

NDC 0228-3481-11

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3481-11)

• Marketing Start Date: 2010-10-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0228-3481-11 [00228348111]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-10-14
• Marketing End Date: 2019-12-31

NDC 0228-3481-50 [00228348150]

Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-10-14
• Marketing End Date: 2015-02-28

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	6.25 mg/1

OpenFDA Data

• SPL SET ID: 41b4da9e-4a9d-45f8-9255-618c94be5a6f
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 854894
  • 854880
• UPC Code:
  • 0302283482116
  • 0302283481119

Pharmacological Class

• gamma-Aminobutyric Acid-ergic Agonist [EPC]
• GABA A Agonists [MoA]
• Pyridines [CS]
• Central Nervous System Depression [PE]

NDC Crossover Matching brand name "Zolpidem Tartrate" or generic name "Zolpidem Tartrate"

NDC	Brand Name	Generic Name
0054-0086	Zolpidem Tartrate	zolpidem tartrate
0054-0087	Zolpidem Tartrate	zolpidem tartrate
0093-0073	Zolpidem Tartrate	Zolpidem Tartrate
0093-0074	Zolpidem Tartrate	Zolpidem Tartrate
67544-996	Zolpidem Tartrate	Zolpidem Tartrate
68071-1895	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68071-1997	Zolpidem Tartrate	Zolpidem Tartrate
68071-1887	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68071-4089	Zolpidem Tartrate	Zolpidem Tartrate
68071-4598	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68084-523	Zolpidem Tartrate	Zolpidem Tartrate
68084-189	Zolpidem Tartrate	Zolpidem Tartrate
68180-779	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68180-780	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68788-7182	Zolpidem Tartrate	Zolpidem Tartrate
68788-7407	Zolpidem Tartrate	Zolpidem Tartrate
68788-9126	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68788-9282	Zolpidem Tartrate	Zolpidem Tartrate
68788-9278	Zolpidem Tartrate	Zolpidem Tartrate
68788-8971	Zolpidem Tartrate	Zolpidem Tartrate
68788-9127	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
68788-8970	Zolpidem Tartrate	Zolpidem Tartrate
70518-0161	Zolpidem Tartrate	Zolpidem Tartrate
70518-1663	Zolpidem Tartrate	Zolpidem Tartrate
71335-0079	Zolpidem Tartrate	Zolpidem Tartrate
71335-0154	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
71335-0283	Zolpidem Tartrate	Zolpidem Tartrate
71335-0134	Zolpidem Tartrate	Zolpidem Tartrate
71610-151	Zolpidem Tartrate	Zolpidem Tartrate
71610-192	Zolpidem Tartrate	Zolpidem Tartrate
71610-152	Zolpidem Tartrate	Zolpidem Tartrate
71610-156	Zolpidem Tartrate	Zolpidem Tartrate
75921-469	Zolpidem Tartrate	Zolpidem Tartrate
0615-8047	Zolpidem Tartrate	Zolpidem Tartrate
0615-8046	Zolpidem Tartrate	Zolpidem Tartrate
0615-8226	Zolpidem Tartrate	Zolpidem Tartrate
0615-8225	Zolpidem Tartrate	Zolpidem Tartrate
0781-5315	Zolpidem tartrate	Zolpidem tartrate
0781-5316	Zolpidem tartrate	Zolpidem tartrate
0781-5318	Zolpidem Tartrate	Zolpidem Tartrate
0781-5317	Zolpidem Tartrate	Zolpidem Tartrate
0904-6082	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
0904-6083	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
0955-1703	Zolpidem Tartrate	Zolpidem Tartrate
10544-539	Zolpidem Tartrate	Zolpidem Tartrate
0955-1702	Zolpidem Tartrate	Zolpidem Tartrate
10544-040	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
10544-548	Zolpidem Tartrate	Zolpidem Tartrate
10544-540	Zolpidem Tartrate	Zolpidem Tartrate
12634-944	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE