NDC 0006-0080

JANUMET XR

Sitagliptin And Metformin Hydrochloride

JANUMET XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Sitagliptin Phosphate; Metformin Hydrochloride.

• Product ID: 0006-0080_34c2aa5e-b8e0-4e56-ad12-6aa8aa4134ff
• NDC: 0006-0080
• Product Type: Human Prescription Drug
• Proprietary Name: JANUMET XR
• Generic Name: Sitagliptin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-02
• Marketing Category: NDA / NDA
• Application Number: NDA202270
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0006-0080-28

2 BOTTLE in 1 CARTON (0006-0080-28) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0080-14)

• Marketing Start Date: 2012-02-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-0080-14 [00006008014]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202270
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-02-02

NDC 0006-0080-82 [00006008082]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202270
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-02

NDC 0006-0080-28 [00006008028]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202270
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-02

NDC 0006-0080-61 [00006008061]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202270
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-02

NDC 0006-0080-62 [00006008062]

JANUMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202270
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-02

Drug Details

Active Ingredients

Ingredient	Strength
SITAGLIPTIN PHOSPHATE	50 mg/1

OpenFDA Data

• SPL SET ID: 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • TS63EW8X6F
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1243833
  • 1243827
  • 1243848
  • 1243843
  • 1243842
  • 1243846
• UPC Code:
  • 0300060081316
  • 0300060080616
  • 0300060078613

Pharmacological Class

• Dipeptidyl Peptidase 4 Inhibitor [EPC]
• Dipeptidyl Peptidase 4 Inhibitors [MoA]
• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "JANUMET XR" or generic name "Sitagliptin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0006-0078	JANUMET	sitagliptin and metformin hydrochloride
0006-0080	JANUMET	sitagliptin and metformin hydrochloride
0006-0081	JANUMET	sitagliptin and metformin hydrochloride
0006-0575	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE
0006-0577	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE
50090-4411	JANUMET	sitagliptin and metformin hydrochloride
50090-5618	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE
70518-2548	JANUMET	SITAGLIPTIN and METFORMIN HYDROCHLORIDE