NDC 0597-0300

Synjardy XR

Empagliflozin, Metformin Hydrochloride

Synjardy XR is a Oral Tablet, Extended Release 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: 0597-0300_2556e57c-d394-4693-b2e9-2b23921abd6b
• NDC: 0597-0300
• Product Type: Human Prescription Drug
• Proprietary Name: Synjardy XR
• Generic Name: Empagliflozin, Metformin Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-10
• Marketing Category: NDA / NDA
• Application Number: NDA208658
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 13 mg/1; mg/1
• Pharm Classes: Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0597-0300-20

1 BOTTLE in 1 CARTON (0597-0300-20) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2016-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0300-20 [00597030020]

Synjardy XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208658
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-10

NDC 0597-0300-45 [00597030045]

Synjardy XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208658
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-10

NDC 0597-0300-93 [00597030093]

Synjardy XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208658
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-10

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	12.5 mg/1

OpenFDA Data

• SPL SET ID: 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • HDC1R2M35U
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1862701
  • 1862700
  • 1862697
  • 1862685
  • 1862695
  • 1862692
  • 1862691
  • 1862688
• UPC Code:
  • 0305970300939

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0597-0280	Synjardy	empagliflozin, metformin hydrochloride
0597-0290	Synjardy	empagliflozin, metformin hydrochloride
0597-0295	Synjardy	empagliflozin, metformin hydrochloride
0597-0300	Synjardy	empagliflozin, metformin hydrochloride