onglyza

Generic: saxagliptin

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name onglyza
Generic Name saxagliptin
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

saxagliptin hydrochloride 5 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-6105
Product ID 0310-6105_0bb7091d-e8c8-4091-9a6b-cbdc6ce4872a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022350
Marketing Start 2014-11-20
Marketing End 2026-03-31

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 03106105
Hyphenated Format 0310-6105

Supplemental Identifiers

RxCUI
858036 858040 858042 858044
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 onglyza (source: ndc)
Generic Name saxagliptin (source: ndc)
Application Number NDA022350 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90)
source: ndc

Packages (2)

0310-6105-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30) 0310-6105-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90)

Ingredients (1)

saxagliptin hydrochloride (5 mg/1)

Linked Drug Pages (1)

ONGLYZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bb7091d-e8c8-4091-9a6b-cbdc6ce4872a", "openfda": {"unii": ["Z8J84YIX6L"], "rxcui": ["858036", "858040", "858042", "858044"], "spl_set_id": ["c5116390-e0fe-4969-94cb-e9de5165fbab"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-30)", "package_ndc": "0310-6105-30", "marketing_end_date": "20260331", "marketing_start_date": "20141218"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6105-90)", "package_ndc": "0310-6105-90", "marketing_end_date": "20260331", "marketing_start_date": "20141219"}], "brand_name": "ONGLYZA", "product_id": "0310-6105_0bb7091d-e8c8-4091-9a6b-cbdc6ce4872a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0310-6105", "generic_name": "SAXAGLIPTIN", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONGLYZA", "active_ingredients": [{"name": "SAXAGLIPTIN HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA022350", "marketing_category": "NDA", "marketing_end_date": "20260331", "marketing_start_date": "20141120"}