NDC 50090-3482

FARXIGA

Dapagliflozin

FARXIGA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Dapagliflozin Propanediol.

• Product ID: 50090-3482_416cb5b3-5237-4ac3-a3b0-bce9d766b2c5
• NDC: 50090-3482
• Product Type: Human Prescription Drug
• Proprietary Name: FARXIGA
• Generic Name: Dapagliflozin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-01-14
• Marketing Category: NDA / NDA
• Application Number: NDA202293
• Labeler Name: A-S Medication Solutions
• Substance Name: DAPAGLIFLOZIN PROPANEDIOL
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50090-3482-0

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3482-0)

• Marketing Start Date: 2018-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-3482-0 [50090348200]

FARXIGA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202293
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-15
• Marketing End Date: 2020-05-18

Drug Details

Active Ingredients

Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	5 mg/1

OpenFDA Data

• SPL SET ID: 01f90c94-71cb-4a1f-81ff-8004b850529b
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 887K2391VH
• RxNorm Concept Unique ID - RxCUI:
  • 1488569
  • 1486977
  • 1486981
  • 1488574

Pharmacological Class

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

NDC Crossover Matching brand name "FARXIGA" or generic name "Dapagliflozin"

NDC	Brand Name	Generic Name
0310-6205	FARXIGA	DAPAGLIFLOZIN
0310-6210	FARXIGA	DAPAGLIFLOZIN
50090-3481	FARXIGA	DAPAGLIFLOZIN
50090-3482	FARXIGA	DAPAGLIFLOZIN
55154-6932	FARXIGA	DAPAGLIFLOZIN
55154-6933	FARXIGA	FARXIGA