JANUMET

Product NDC
50090-5504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sitagliptin and metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA202270
Marketing category
NDA
Substance
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
50090-5504-060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0) 2021-03-31NoHistorical
50090-5504-1180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-1) 2021-09-01NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
JANUMET XRA-S Medication Solutions2023-06-16HUMAN PRESCRIPTION DRUG LABEL7