dapagliflozin

Generic: dapagliflozin

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dapagliflozin
Generic Name dapagliflozin
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dapagliflozin propanediol 10 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-457
Product ID 66993-457_8d1c787c-dc29-4d26-bc99-77eeca055b8c
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 66993457
Hyphenated Format 66993-457

Supplemental Identifiers

RxCUI
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 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, PLASTIC (66993-457-30)
source: ndc

Packages (1)

66993-457-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-457-30)

Ingredients (1)

dapagliflozin propanediol (10 mg/1)

Linked Drug Pages (1)

DAPAGLIFLOZIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d1c787c-dc29-4d26-bc99-77eeca055b8c", "openfda": {"unii": ["887K2391VH"], "rxcui": ["1488569", "1488574"], "spl_set_id": ["3aba33aa-f8c6-4b10-85c8-dfa14578d07c"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-457-30)", "package_ndc": "66993-457-30", "marketing_start_date": "20240103"}], "brand_name": "DAPAGLIFLOZIN", "product_id": "66993-457_8d1c787c-dc29-4d26-bc99-77eeca055b8c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "66993-457", "generic_name": "DAPAGLIFLOZIN", "labeler_name": "Prasco Laboratories", "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"}