dapagliflozin and metformin hydrochloride

Generic: dapagliflozin and metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name dapagliflozin and metformin hydrochloride
Generic Name dapagliflozin and metformin hydrochloride
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dapagliflozin propanediol 5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-361
Product ID 66993-361_8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA205649
Listing Expiration 2026-12-31
Marketing Start 2024-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993361
Hyphenated Format 66993-361

Supplemental Identifiers

RxCUI
1593058 1593070
UNII
887K2391VH 786Z46389E

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 and metformin hydrochloride (source: ndc)
Generic Name dapagliflozin and metformin hydrochloride (source: ndc)
Application Number NDA205649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)
source: ndc

Packages (1)

66993-361-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)

Ingredients (2)

dapagliflozin propanediol (5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

dapagliflozin and metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5", "openfda": {"unii": ["887K2391VH", "786Z46389E"], "rxcui": ["1593058", "1593070"], "spl_set_id": ["eaf135b6-e378-4f62-a1e7-db45e23668c7"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)", "package_ndc": "66993-361-60", "marketing_start_date": "20240103"}], "brand_name": "dapagliflozin and metformin hydrochloride", "product_id": "66993-361_8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "66993-361", "generic_name": "dapagliflozin and metformin hydrochloride", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dapagliflozin and metformin hydrochloride", "active_ingredients": [{"name": "DAPAGLIFLOZIN PROPANEDIOL", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA205649", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240103", "listing_expiration_date": "20261231"}