saxagliptin and metformin (0378-8177)

Drug Facts

Product Profile

Brand Name saxagliptin and metformin

Generic Name saxagliptin and metformin

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

metformin hydrochloride 1000 mg/1, saxagliptin hydrochloride dihydrate 5 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8177

Product ID 0378-8177_899afa1b-4ad3-4848-8810-7e215cd32df0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205981

Listing Expiration 2026-12-31

Marketing Start 2023-08-08

Pharmacologic Class

Classes

biguanide [epc] biguanides [cs] dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788177

Hyphenated Format 0378-8177

Supplemental Identifiers

RxCUI

1043563 1043570 1043578

UPC

0303788176913

UNII

4N19ON48ZN 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 saxagliptin and metformin (source: ndc)

Generic Name saxagliptin and metformin (source: ndc)

Application Number ANDA205981 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1000 mg/1
5 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8177-93)

source: ndc

Packages (1)

0378-8177-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8177-93)

Ingredients (2)

metformin hydrochloride (1000 mg/1) saxagliptin hydrochloride dihydrate (5 mg/1)

Linked Drug Pages (1)

Saxagliptin and Metformin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "899afa1b-4ad3-4848-8810-7e215cd32df0", "openfda": {"upc": ["0303788176913"], "unii": ["4N19ON48ZN", "786Z46389E"], "rxcui": ["1043563", "1043570", "1043578"], "spl_set_id": ["cbf8677c-cafe-48bc-8844-0cc6547886bd"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8177-93)", "package_ndc": "0378-8177-93", "marketing_start_date": "20230808"}], "brand_name": "Saxagliptin and Metformin", "product_id": "0378-8177_899afa1b-4ad3-4848-8810-7e215cd32df0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0378-8177", "generic_name": "saxagliptin and metformin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Saxagliptin and Metformin", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}, {"name": "SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE", "strength": "5 mg/1"}], "application_number": "ANDA205981", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}