NDC 70518-1986

Jardiance

Empagliflozin

Jardiance is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Empagliflozin.

• Product ID: 70518-1986_851997d7-cb50-17bf-e053-2a91aa0ab78b
• NDC: 70518-1986
• Product Type: Human Prescription Drug
• Proprietary Name: Jardiance
• Generic Name: Empagliflozin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-27
• Marketing Category: NDA / NDA
• Application Number: NDA204629
• Labeler Name: REMEDYREPACK INC.
• Substance Name: EMPAGLIFLOZIN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-1986-0

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1986-0)

• Marketing Start Date: 2019-03-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1986-0 [70518198600]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-27

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	10 mg/1

OpenFDA Data

• SPL SET ID: 95f4b2ad-2c58-470f-a227-b0096c0f84fa
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • HDC1R2M35U
• RxNorm Concept Unique ID - RxCUI:
  • 1545658
  • 1545664

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