NDC 0037-6010

Edluar

Zolpidem Tartrate

Edluar is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Zolpidem Tartrate.

• Product ID: 0037-6010_2ba4ee31-fd16-45e7-bedb-68770a0bc5c8
• NDC: 0037-6010
• Product Type: Human Prescription Drug
• Proprietary Name: Edluar
• Generic Name: Zolpidem Tartrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-24
• Marketing Category: NDA / NDA
• Application Number: NDA021997
• Labeler Name: Meda Pharmaceuticals
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0037-6010-02

20 BLISTER PACK in 1 BOX, UNIT-DOSE (0037-6010-02) > 2 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2009-07-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-6010-30 [00037601030]

Edluar TABLET

• Marketing Category: NDA
• Application Number: NDA021997
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-24

NDC 0037-6010-02 [00037601002]

Edluar TABLET

• Marketing Category: NDA
• Application Number: NDA021997
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-24

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	10 mg/1

OpenFDA Data

• SPL SET ID: a32884d0-85b5-11de-8a39-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 836641
  • 836649
  • 836645
  • 836647

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0037-6010	Edluar	Zolpidem Tartrate
0037-6050	Edluar	Zolpidem Tartrate
0024-5401	Ambien	zolpidem tartrate
0024-5421	Ambien	zolpidem tartrate
0024-5501	Ambien	zolpidem tartrate
0024-5521	Ambien	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