NDC 71610-177

Jardiance

Empagliflozin

Jardiance is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Empagliflozin.

• Product ID: 71610-177_75491ff1-aa83-4d04-89ad-1137b2838e7a
• NDC: 71610-177
• Product Type: Human Prescription Drug
• Proprietary Name: Jardiance
• Generic Name: Empagliflozin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA204629
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: EMPAGLIFLOZIN
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 71610-177-09

9000 TABLET, FILM COATED in 1 BOTTLE (71610-177-09)

• Marketing Start Date: 2018-10-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71610-177-09 [71610017709]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-24

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	25 mg/1

OpenFDA Data

• SPL SET ID: 8b6261f6-4bdc-462e-8af1-4064664c62f3
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • HDC1R2M35U
• RxNorm Concept Unique ID - RxCUI:
  • 1545668
  • 1545666

Pharmacological Class

• Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
• Sodium-Glucose Transporter 2 Inhibitors [MoA]
• Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
• Sodium-Glucose Transporter 2 Inhibitors [MoA]

NDC Crossover Matching brand name "Jardiance" or generic name "Empagliflozin"

NDC	Brand Name	Generic Name
0597-0152	Jardiance	Empagliflozin
0597-0153	Jardiance	Empagliflozin
50090-4384	Jardiance	Empagliflozin
50090-4492	Jardiance	Empagliflozin
55154-0411	Jardiance	Empagliflozin
55154-0412	Jardiance	Empagliflozin
70518-1986	Jardiance	Empagliflozin
70518-2447	Jardiance	Empagliflozin
71610-177	Jardiance	Empagliflozin