NDC 0597-0153

Jardiance

Empagliflozin

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

• Product ID: 0597-0153_02876238-d0b0-4fa5-85e4-b7cb7787b5a7
• NDC: 0597-0153
• 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: Boehringer Ingelheim Pharmaceuticals, Inc.
• 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: 2022-12-31

Packaging

NDC 0597-0153-07

1 BOTTLE in 1 CARTON (0597-0153-07) > 7 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2014-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0153-90 [00597015390]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-01

NDC 0597-0153-30 [00597015330]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-01

NDC 0597-0153-07 [00597015307]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-08-01

NDC 0597-0153-37 [00597015337]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-08-01

NDC 0597-0153-70 [00597015370]

Jardiance TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-08-01

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	25 mg/1

OpenFDA Data

• SPL SET ID: faf3dd6a-9cd0-39c2-0d2e-232cb3f67565
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • HDC1R2M35U
• RxNorm Concept Unique ID - RxCUI:
  • 1545668
  • 1545658
  • 1545666
  • 1545664

Pharmacological Class

• 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