saxagliptin

Generic: saxagliptin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name saxagliptin
Generic Name saxagliptin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

saxagliptin hydrochloride 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-826
Product ID 65862-826_ac9f5784-0c62-42f2-bc34-4cef2486b7f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205972
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

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 65862826
Hyphenated Format 65862-826

Supplemental Identifiers

RxCUI
858036 858042
UPC
0365862825308 0365862826305
UNII
Z8J84YIX6L

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 ANDA205972 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-826-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-826-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-826-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-826-90)
source: ndc

Packages (4)

65862-826-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-826-01) 65862-826-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-826-05) 65862-826-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-826-30) 65862-826-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-826-90)

Ingredients (1)

saxagliptin hydrochloride (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": "ac9f5784-0c62-42f2-bc34-4cef2486b7f7", "openfda": {"upc": ["0365862825308", "0365862826305"], "unii": ["Z8J84YIX6L"], "rxcui": ["858036", "858042"], "spl_set_id": ["f3ea58bb-0002-4a5d-9213-7e9066e3dc9c"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-826-01)", "package_ndc": "65862-826-01", "marketing_start_date": "20230731"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-826-05)", "package_ndc": "65862-826-05", "marketing_start_date": "20230731"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-826-30)", "package_ndc": "65862-826-30", "marketing_start_date": "20230731"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-826-90)", "package_ndc": "65862-826-90", "marketing_start_date": "20230731"}], "brand_name": "Saxagliptin", "product_id": "65862-826_ac9f5784-0c62-42f2-bc34-4cef2486b7f7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "65862-826", "generic_name": "Saxagliptin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Saxagliptin", "active_ingredients": [{"name": "SAXAGLIPTIN HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA205972", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}