FDA.reportPublic FDA data

JANUVIA

Product NDC
50090-5585
11-digit product format
500905585
Labeler code
50090
Product ID
50090-5585_cfeddd56-d91c-42ee-91d2-98e5cf752e55
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
50090-5585-02023-02-07C16284748780-1f386c64a-0e16-0266-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
50090-5585-12023-02-07C16284748780-1f386c64a-0e16-0266-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
50090-5585-02023-01-30C16284748780-1f386c64a-0e16-0266-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
50090-5585-12023-01-30C16284748780-1f386c64a-0e16-0266-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
50090-5585-0JANUVIA30 in 1 BOTTLETABLET, FILM COATED306
50090-5585-1JANUVIA90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5585-0EA - Each50090-55859ca7ac49-b185-45de-80e4-69ae6d052a5912022-04-06
50090-5585-1EA - Each50090-5585bf4f5d93-e7bc-45ae-92b1-42857da4902f12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5585JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20230617_24e22e28-ec43-47e8-969f-788268ccba12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665036Januvia 100 MG Oral TabletPSN24e22e28-ec43-47e8-969f-788268ccba126
2709603SITagliptin phosphate 100 MG Oral TabletPSN24e22e28-ec43-47e8-969f-788268ccba126
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBD24e22e28-ec43-47e8-969f-788268ccba126
2709603sitagliptin phosphate 100 MG Oral TabletSCD24e22e28-ec43-47e8-969f-788268ccba126
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSY24e22e28-ec43-47e8-969f-788268ccba126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5585-05009055850030 TABLET, FILM COATED in 1 BOTTLE (50090-5585-0) 2021-07-090000-00-00NoNoCurrent
50090-5585-15009055850190 TABLET, FILM COATED in 1 BOTTLE (50090-5585-1) 2021-07-090000-00-00NoNoCurrent