NDC 0310-6205

FARXIGA

Dapagliflozin

FARXIGA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Dapagliflozin Propanediol.

• Product ID: 0310-6205_05eedd34-9c14-4d91-b36c-b661eff3401e
• NDC: 0310-6205
• 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: AstraZeneca Pharmaceuticals LP
• 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: 2023-12-31

Packaging

NDC 0310-6205-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)

• Marketing Start Date: 2015-02-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6205-95 [00310620595]

FARXIGA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202293
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-02-02

NDC 0310-6205-30 [00310620530]

FARXIGA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202293
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-02

Drug Details

Active Ingredients

Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	5 mg/1

OpenFDA Data

• SPL SET ID: 72ad22ae-efe6-4cd6-a302-98aaee423d69
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 887K2391VH
• RxNorm Concept Unique ID - RxCUI:
  • 1488569
  • 1486977
  • 1486981
  • 1488574
• UPC Code:
  • 0300000000001

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