NDC 52959-879

ZOLPIDEM TARTRATE

Zolpidem Tartrate

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

• Product ID: 52959-879_5d59fb92-77d7-bcd0-e053-2991aa0ac409
• NDC: 52959-879
• Product Type: Human Prescription Drug
• Proprietary Name: ZOLPIDEM TARTRATE
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077903
• Labeler Name: H.J Harkins Company 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52959-879-15

15 TABLET in 1 BOTTLE (52959-879-15)

• Marketing Start Date: 2017-01-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52959-879-10 [52959087910]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-16
• Inactivation Date: 2020-01-31

NDC 52959-879-60 [52959087960]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-03
• Inactivation Date: 2020-01-31

NDC 52959-879-20 [52959087920]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-03
• Inactivation Date: 2020-01-31

NDC 52959-879-15 [52959087915]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-03
• Inactivation Date: 2020-01-31

NDC 52959-879-00 [52959087900]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077903
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-03
• Inactivation Date: 2020-01-31

NDC 52959-879-30 [52959087930]

ZOLPIDEM TARTRATE TABLET

• Marketing Category: ANDA
• Application Number: ANDA077903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-03
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	5 mg/1

OpenFDA Data

• SPL SET ID: 5d59fb92-77d6-bcd0-e053-2991aa0ac409
• Manufacturer:
  • H.J Harkins Company Inc.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 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