QTERN

Generic: dapagliflozin and saxagliptin

Labeler: AstraZeneca Pharmaceuticals LP
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive

Drug Facts

Product Profile

Brand Name QTERN
Generic Name dapagliflozin and saxagliptin
Labeler AstraZeneca Pharmaceuticals LP
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

DAPAGLIFLOZIN 5 mg/1, SAXAGLIPTIN HYDROCHLORIDE 5 mg/1

Identifiers & Regulatory

Product NDC 0310-6770
Product ID 0310-6770_d675ddaa-3a40-4323-9edd-b04f13f10a03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209091
Marketing Start 2017-12-04
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03106770
Hyphenated Format 0310-6770

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 QTERN (source: ndc)
Generic Name dapagliflozin and saxagliptin (source: ndc)
Application Number NDA209091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)
source: ndc

Packages (1)

0310-6770-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)

Ingredients (2)

DAPAGLIFLOZIN (5 mg/1) SAXAGLIPTIN HYDROCHLORIDE (5 mg/1)

Linked Drug Pages (1)

QTERN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d675ddaa-3a40-4323-9edd-b04f13f10a03", "openfda": {"nui": ["N0000187059", "N0000187058"], "unii": ["1ULL0QJ8UC", "Z8J84YIX6L"], "rxcui": ["1925498", "1925504", "2169274", "2169276"], "spl_set_id": ["423c489c-085b-4320-b892-7868ebd6dc6b"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)", "package_ndc": "0310-6770-30", "marketing_end_date": "20260228", "marketing_start_date": "20190617"}], "brand_name": "QTERN", "product_id": "0310-6770_d675ddaa-3a40-4323-9edd-b04f13f10a03", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0310-6770", "generic_name": "dapagliflozin and saxagliptin", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QTERN", "active_ingredients": [{"name": "DAPAGLIFLOZIN", "strength": "5 mg/1"}, {"name": "SAXAGLIPTIN HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA209091", "marketing_category": "NDA", "marketing_end_date": "20260228", "marketing_start_date": "20171204"}