JANUVIA

Product NDC
50090-5517
11-digit product format
500905517
Labeler code
50090
Product ID
50090-5517_d282a667-04f0-4e97-8d6f-963ee965fe94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sitagliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021995
Marketing category
NDA
Marketing start
2006-10-16
Marketing end
0000-00-00
Substance
SITAGLIPTIN PHOSPHATE
Active strength
50 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5517-0EA - Each50090-551749690f19-22d6-4cc7-a18b-f7d35de3e62512022-04-06
50090-5517-1EA - Each50090-55175de5a6fd-7792-46d2-9382-782d82d23c4b12022-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5517-05009055170030 TABLET, FILM COATED in 1 BOTTLE (50090-5517-0) 2021-04-130000-00-00NoNoCurrent
50090-5517-15009055170190 TABLET, FILM COATED in 1 BOTTLE (50090-5517-1) 2022-04-020000-00-00NoNoCurrent