dapagliflozin

Generic: dapagliflozin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dapagliflozin
Generic Name dapagliflozin
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dapagliflozin propanediol 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-3253
Product ID 63629-3253_4ef8db0b-c28e-44ff-bf60-a9f8018c5861
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA202293
Listing Expiration 2026-12-31
Marketing Start 2024-01-03

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 636293253
Hyphenated Format 63629-3253

Supplemental Identifiers

RxCUI
1488569
UNII
887K2391VH

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

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-3253-1)
source: ndc

Packages (1)

Ingredients (1)

dapagliflozin propanediol (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4ef8db0b-c28e-44ff-bf60-a9f8018c5861", "openfda": {"unii": ["887K2391VH"], "rxcui": ["1488569"], "spl_set_id": ["979205ee-b0b8-4483-ae61-f283f750bb7f"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-3253-1)", "package_ndc": "63629-3253-1", "marketing_start_date": "20240124"}], "brand_name": "DAPAGLIFLOZIN", "product_id": "63629-3253_4ef8db0b-c28e-44ff-bf60-a9f8018c5861", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "63629-3253", "generic_name": "DAPAGLIFLOZIN", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DAPAGLIFLOZIN", "active_ingredients": [{"name": "DAPAGLIFLOZIN PROPANEDIOL", "strength": "10 mg/1"}], "application_number": "NDA202293", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240103", "listing_expiration_date": "20261231"}