JANUMET

Product NDC
50090-5618
11-digit product format
500905618
Labeler code
50090
Product ID
50090-5618_c078d91a-3a2c-4344-aa9e-415b63157d02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA022044
Marketing category
NDA
Marketing start
2007-03-30
Marketing end
0000-00-00
Substance
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength
50 mg/1; mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5618-02023-02-06C16284748780-1f386c649-9990-0266-e053-dadaa90a7c1a5b88ac15-87ff-42d9-9dd3-8b87a2fea967
50090-5618-02023-01-30C16284748780-1f386c649-9990-0266-e053-dadaa90a7c1a5b88ac15-87ff-42d9-9dd3-8b87a2fea967

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5618-0EA - Each50090-5618f08afde8-e4c3-430f-a508-7f524c7c9da712022-04-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5618-05009056180060 TABLET, FILM COATED in 1 BOTTLE (50090-5618-0) 2021-08-240000-00-00NoNoCurrent