xigduo xr

Generic: dapagliflozin and metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name xigduo xr
Generic Name dapagliflozin and metformin hydrochloride
Labeler astrazeneca pharmaceuticals lp
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dapagliflozin propanediol 5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-6260
Product ID 0310-6260_a8717b28-9445-4292-9ac7-e979f378d9c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205649
Listing Expiration 2026-12-31
Marketing Start 2014-10-29

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] sodium-glucose cotransporter 2 inhibitor [epc] sodium-glucose transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03106260
Hyphenated Format 0310-6260

Supplemental Identifiers

RxCUI
1593058 1593068 1593070 1593072 1593775 1593831 1593833 1593835 1940496 1940498
UNII
887K2391VH 786Z46389E

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 xigduo xr (source: ndc)
Generic Name dapagliflozin and metformin hydrochloride (source: ndc)
Application Number NDA205649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60)
  • 1 BLISTER PACK in 1 CARTON (0310-6260-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

0310-6260-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60) 0310-6260-95 1 BLISTER PACK in 1 CARTON (0310-6260-95) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dapagliflozin propanediol (5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

XIGDUO XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a8717b28-9445-4292-9ac7-e979f378d9c8", "openfda": {"unii": ["887K2391VH", "786Z46389E"], "rxcui": ["1593058", "1593068", "1593070", "1593072", "1593775", "1593831", "1593833", "1593835", "1940496", "1940498"], "spl_set_id": ["ac8a0f7b-9f69-4495-abbc-3a47cd75a859"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6260-60)", "package_ndc": "0310-6260-60", "marketing_start_date": "20141111"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (0310-6260-95)  / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0310-6260-95", "marketing_start_date": "20141111"}], "brand_name": "XIGDUO XR", "product_id": "0310-6260_a8717b28-9445-4292-9ac7-e979f378d9c8", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "0310-6260", "generic_name": "dapagliflozin and metformin hydrochloride", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XIGDUO", "brand_name_suffix": "XR", "active_ingredients": [{"name": "DAPAGLIFLOZIN PROPANEDIOL", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA205649", "marketing_category": "NDA", "marketing_start_date": "20141029", "listing_expiration_date": "20261231"}