saxagliptin

Generic: saxagliptin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name saxagliptin
Generic Name saxagliptin
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

saxagliptin hydrochloride dihydrate 2.5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4705
Product ID 0378-4705_5844f950-ed79-43de-a6c4-2233878a9222
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205980
Listing Expiration 2026-12-31
Marketing Start 2023-08-04

Pharmacologic Class

Classes
dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03784705
Hyphenated Format 0378-4705

Supplemental Identifiers

RxCUI
858036 858042
UPC
0303784705933
UNII
4N19ON48ZN

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 (source: ndc)
Generic Name saxagliptin (source: ndc)
Application Number ANDA205980 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-93)
source: ndc

Packages (2)

0378-4705-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77) 0378-4705-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-93)

Ingredients (1)

saxagliptin hydrochloride dihydrate (2.5 mg/1)

Linked Drug Pages (1)

Saxagliptin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5844f950-ed79-43de-a6c4-2233878a9222", "openfda": {"upc": ["0303784705933"], "unii": ["4N19ON48ZN"], "rxcui": ["858036", "858042"], "spl_set_id": ["6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77)", "package_ndc": "0378-4705-77", "marketing_start_date": "20230804"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-93)", "package_ndc": "0378-4705-93", "marketing_start_date": "20230804"}], "brand_name": "Saxagliptin", "product_id": "0378-4705_5844f950-ed79-43de-a6c4-2233878a9222", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0378-4705", "generic_name": "saxagliptin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Saxagliptin", "active_ingredients": [{"name": "SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE", "strength": "2.5 mg/1"}], "application_number": "ANDA205980", "marketing_category": "ANDA", "marketing_start_date": "20230804", "listing_expiration_date": "20261231"}