saxagliptin

Generic: saxagliptin

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

saxagliptin hydrochloride 5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-727
Product ID 68462-727_4d1a25c6-4ffc-4714-98a9-c4dcb2049d6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205994
Listing Expiration 2027-12-31
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 68462727
Hyphenated Format 68462-727

Supplemental Identifiers

RxCUI
858036 858042
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 ANDA205994 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05)
  • 10 BLISTER PACK in 1 CARTON (68462-727-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-727-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68462-727-90)
source: ndc

Packages (4)

68462-727-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05) 68462-727-14 10 BLISTER PACK in 1 CARTON (68462-727-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK 68462-727-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-727-30) 68462-727-90 90 TABLET, FILM COATED in 1 BOTTLE (68462-727-90)

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": "4d1a25c6-4ffc-4714-98a9-c4dcb2049d6d", "openfda": {"unii": ["Z8J84YIX6L"], "rxcui": ["858036", "858042"], "spl_set_id": ["e286ffd4-c598-47fb-af06-2e15f7e6f99f"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05)", "package_ndc": "68462-727-05", "marketing_start_date": "20230731"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-727-14)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-727-14", "marketing_start_date": "20230731"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-727-30)", "package_ndc": "68462-727-30", "marketing_start_date": "20230731"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68462-727-90)", "package_ndc": "68462-727-90", "marketing_start_date": "20230731"}], "brand_name": "SAXAGLIPTIN", "product_id": "68462-727_4d1a25c6-4ffc-4714-98a9-c4dcb2049d6d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "68462-727", "generic_name": "SAXAGLIPTIN", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SAXAGLIPTIN", "active_ingredients": [{"name": "SAXAGLIPTIN HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA205994", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20271231"}