NDC 0143-9963

Zolpidem

Zolpidem Tartrate

Zolpidem is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceutical Corp. The primary component is Zolpidem Tartrate.

• Product ID: 0143-9963_44d3d32b-6e68-4915-920e-ede52ed92f26
• NDC: 0143-9963
• Product Type: Human Prescription Drug
• Proprietary Name: Zolpidem
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-04-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078129
• Labeler Name: West-ward Pharmaceutical Corp
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 10 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 0143-9963-01

100 TABLET in 1 BOTTLE (0143-9963-01)

• Marketing Start Date: 2008-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0143-9963-01 [00143996301]

Zolpidem TABLET

• Marketing Category: ANDA
• Application Number: ANDA078129
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-04-30

NDC 0143-9963-05 [00143996305]

Zolpidem TABLET

• Marketing Category: ANDA
• Application Number: ANDA078129
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-04-30

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	10 mg/1

OpenFDA Data

• SPL SET ID: 313ccc9f-7b3e-4e42-b5d8-0e27c3c72d8e
• Manufacturer:
  • West-ward Pharmaceutical Corp
• 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" or generic name "Zolpidem Tartrate"

NDC	Brand Name	Generic Name
0143-9962	Zolpidem	Zolpidem
0143-9963	Zolpidem	Zolpidem
71093-156	Zolpidem	Zolpidem
71093-155	Zolpidem	Zolpidem
63629-1170	Zolpidem	Zolpidem
63629-1171	Zolpidem	Zolpidem
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