NDC 0310-6250

XIGDUO XR

Dapagliflozin And Metformin Hydrochloride

XIGDUO XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Dapagliflozin Propanediol; Metformin Hydrochloride.

• Product ID: 0310-6250_0b81ae18-d86b-41ab-86eb-fb920b30d791
• NDC: 0310-6250
• Product Type: Human Prescription Drug
• Proprietary Name: XIGDUO XR
• Generic Name: Dapagliflozin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-29
• Marketing Category: NDA / NDA
• Application Number: NDA205649
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0310-6250-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6250-30)

• Marketing Start Date: 2014-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6250-95 [00310625095]

XIGDUO XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205649
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-12-01

NDC 0310-6250-30 [00310625030]

XIGDUO XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205649
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-01

Drug Details

Active Ingredients

Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	5 mg/1

OpenFDA Data

• SPL SET ID: ac8a0f7b-9f69-4495-abbc-3a47cd75a859
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 887K2391VH
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1593058
  • 1593775
  • 1940496
  • 1593068
  • 1940498
  • 1593070
  • 1593835
  • 1593072
  • 1593831
  • 1593833
• UPC Code:
  • 0303106270309
  • 0303106260607
  • 0303106225606
  • 0303106250301

Pharmacological Class

• Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
• Sodium-Glucose Transporter 2 Inhibitors [MoA]
• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "XIGDUO XR" or generic name "Dapagliflozin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride