NDC 12634-943

ZOLPIDEM TARTRATE

Zolpidem Tartrate

ZOLPIDEM TARTRATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotheca, Inc. The primary component is Zolpidem Tartrate.

• Product ID: 12634-943_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4
• NDC: 12634-943
• Product Type: Human Prescription Drug
• Proprietary Name: ZOLPIDEM TARTRATE
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2007-07-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077884
• Labeler Name: APOTHECA, INC
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 5 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: 2019-12-31

Packaging

NDC 12634-943-91

1 TABLET in 1 BLISTER PACK (12634-943-91)

• Marketing Start Date: 2007-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 12634-943-00 [12634094300]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077884
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-07-25
• Inactivation Date: 2020-01-31

NDC 12634-943-95 [12634094395]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077884
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-07-25
• Inactivation Date: 2020-01-31

NDC 12634-943-91 [12634094391]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077884
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-07-25
• Inactivation Date: 2020-01-31

NDC 12634-943-71 [12634094371]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077884
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-07-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	5 mg/1

OpenFDA Data

• SPL SET ID: 7638e2bd-04c5-4ad2-8635-fb460ab4d1c3
• Manufacturer:
  • APOTHECA, INC
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 854873
  • 854876

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