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 ID70518-2548_9c9f759b-9816-70dd-e053-2995a90a395c
NDC70518-2548
Product TypeHuman Prescription Drug
Proprietary NameJANUMET
Generic NameSitagliptin And Metformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-20
Marketing CategoryNDA /
Application NumberNDA022044
Labeler NameREMEDYREPACK INC.
Substance NameSITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70518-2548-0

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2548-0)
Marketing Start Date2020-01-20
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0006-0078JANUMETsitagliptin and metformin hydrochloride
0006-0080JANUMETsitagliptin and metformin hydrochloride
0006-0081JANUMETsitagliptin and metformin hydrochloride
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE
70518-2548JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDE

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