farxiga

Generic: dapagliflozin

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name farxiga
Generic Name dapagliflozin
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dapagliflozin propanediol 5 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-6205
Product ID 0310-6205_eed62fae-225f-4a73-b778-fe2bbdb3656a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202293
Listing Expiration 2026-12-31
Marketing Start 2008-01-14

Pharmacologic Class

Classes
sodium-glucose cotransporter 2 inhibitor [epc] sodium-glucose transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03106205
Hyphenated Format 0310-6205

Supplemental Identifiers

RxCUI
1486977 1486981 1488569 1488574
UNII
887K2391VH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name farxiga (source: ndc)
Generic Name dapagliflozin (source: ndc)
Application Number NDA202293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90)
  • 1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

0310-6205-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30) 0310-6205-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90) 0310-6205-95 1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

dapagliflozin propanediol (5 mg/1)

Linked Drug Pages (1)

FARXIGA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eed62fae-225f-4a73-b778-fe2bbdb3656a", "openfda": {"unii": ["887K2391VH"], "rxcui": ["1486977", "1486981", "1488569", "1488574"], "spl_set_id": ["72ad22ae-efe6-4cd6-a302-98aaee423d69"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)", "package_ndc": "0310-6205-30", "marketing_start_date": "20150202"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90)", "package_ndc": "0310-6205-90", "marketing_start_date": "20240318"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (0310-6205-95)  / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0310-6205-95", "marketing_start_date": "20150202"}], "brand_name": "FARXIGA", "product_id": "0310-6205_eed62fae-225f-4a73-b778-fe2bbdb3656a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0310-6205", "generic_name": "DAPAGLIFLOZIN", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FARXIGA", "active_ingredients": [{"name": "DAPAGLIFLOZIN PROPANEDIOL", "strength": "5 mg/1"}], "application_number": "NDA202293", "marketing_category": "NDA", "marketing_start_date": "20080114", "listing_expiration_date": "20261231"}