NDC 70518-2548

JANUMET

Sitagliptin And Metformin Hydrochloride

JANUMET is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Sitagliptin Phosphate; Metformin Hydrochloride.

• Product ID: 70518-2548_9c9f759b-9816-70dd-e053-2995a90a395c
• NDC: 70518-2548
• Product Type: Human Prescription Drug
• Proprietary Name: JANUMET
• Generic Name: Sitagliptin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2020-01-20
• Marketing Category: NDA / NDA
• Application Number: NDA022044
• Labeler Name: REMEDYREPACK INC.
• 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 70518-2548-0

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2548-0)

• Marketing Start Date: 2020-01-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2548-0 [70518254800]

JANUMET TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022044
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-20

Drug Details

Active Ingredients

Ingredient	Strength
SITAGLIPTIN PHOSPHATE	50 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "JANUMET" 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