NDC 0597-0159

Synjardy

Empagliflozin And Metformin Hydrochloride

Synjardy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Empagliflozin; Metformin Hydrochloride.

• Product ID: 0597-0159_2f7eaca8-aa25-162f-af59-8682293e8590
• NDC: 0597-0159
• Product Type: Human Prescription Drug
• Proprietary Name: Synjardy
• Generic Name: Empagliflozin And Metformin Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-26
• Marketing Category: NDA / NDA
• Application Number: NDA206111
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0597-0159-18

180 TABLET in 1 BOTTLE (0597-0159-18)

• Marketing Start Date: 2015-09-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0159-60 [00597015960]

Synjardy TABLET

• Marketing Category: NDA
• Application Number: NDA206111
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-12

NDC 0597-0159-18 [00597015918]

Synjardy TABLET

• Marketing Category: NDA
• Application Number: NDA206111
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-12

NDC 0597-0159-66 [00597015966]

Synjardy TABLET

• Marketing Category: NDA
• Application Number: NDA206111
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-12

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	5 mg/1

OpenFDA Data

• SPL SET ID: 0fdd0255-0055-65f3-b2c0-db8fbb87beae
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • HDC1R2M35U
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1664315
  • 1665367
  • 1664328
  • 1664326
  • 1664325
  • 1664323
  • 1664321
  • 1665369
• UPC Code:
  • 0305970175186
  • 0305970159605
  • 0305970168188

Pharmacological Class

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

NDC Crossover Matching brand name "Synjardy" or generic name "Empagliflozin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0597-0159	Synjardy	empagliflozin and metformin hydrochloride
0597-0168	Synjardy	empagliflozin and metformin hydrochloride
0597-0175	Synjardy	empagliflozin and metformin hydrochloride
0597-0180	Synjardy	empagliflozin and metformin hydrochloride
0597-0280	Synjardy	empagliflozin, metformin hydrochloride
0597-0290	Synjardy	empagliflozin, metformin hydrochloride
0597-0295	Synjardy	empagliflozin, metformin hydrochloride
0597-0300	Synjardy	empagliflozin, metformin hydrochloride