FDA.reportPublic FDA data

JANUVIA

Product NDC
50090-4084
11-digit product format
500904084
Labeler code
50090
Product ID
50090-4084_d8082759-1a42-485b-9dbc-7a3d5751a5ee
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
Substance
SITAGLIPTIN PHOSPHATE
Active strength
100 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
JANUVIA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SITAGLIPTIN PHOSPHATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTS63EW8X6F
Rxcui665036, 2709603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
19a549d9-1cb9-4833-ba02-91db3dcb07baProduct name120251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79Product name120250630
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
fd232072-39c4-4416-9b66-265d18a7bd93Product name120180306
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4084-02023-02-07C16284748780-1f386c649-c0e1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA ® (sitagliptin) tablets, for oral use Initial U.S. Approval: 2006
50090-4084-02023-01-30C16284748780-1f386c649-c0e1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA ® (sitagliptin) tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4084-0JANUVIA90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4084-0EA - Each50090-408406c6d411-9213-4848-abcb-e5e7d0cdc64312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4084JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20230617_62c4f58b-2b28-4825-aeb6-213ab9b7a026.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665036Januvia 100 MG Oral TabletPSN62c4f58b-2b28-4825-aeb6-213ab9b7a0269
2709603SITagliptin phosphate 100 MG Oral TabletPSN62c4f58b-2b28-4825-aeb6-213ab9b7a0269
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBD62c4f58b-2b28-4825-aeb6-213ab9b7a0269
2709603sitagliptin phosphate 100 MG Oral TabletSCD62c4f58b-2b28-4825-aeb6-213ab9b7a0269
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSY62c4f58b-2b28-4825-aeb6-213ab9b7a0269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4084-05009040840090 TABLET, FILM COATED in 1 BOTTLE (50090-4084-0) 2019-01-240000-00-00NoNoCurrent