FDA.reportPublic FDA data

JANUVIA

Product NDC
50090-3527
11-digit product format
500903527
Labeler code
50090
Product ID
50090-3527_7c7617c5-0136-4470-ae12-92e0a578c883
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
25 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 PHOSPHATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTS63EW8X6F
Rxcui665040, 2709612

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50090-3527-02023-07-21C16284748780-1f386c649-c376-0266-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
50090-3527-02023-01-30C16284748780-1f386c649-c376-0266-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
50090-3527-0JANUVIA90 in 1 BOTTLETABLET, FILM COATED907
50090-3527-1JANUVIA30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3527-0EA - Each50090-35278bc34cb4-fcde-4a63-95f0-68bc6f13da4712023-08-08
50090-3527-1EA - Each50090-3527ad68928e-9d17-4363-b416-891d54f1ea0b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3527JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230721_1b03c82f-b52e-4092-b9dc-f2c9b0d6ab40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665040Januvia 25 MG Oral TabletPSN1b03c82f-b52e-4092-b9dc-f2c9b0d6ab407
2709612SITagliptin phosphate 25 MG Oral TabletPSN1b03c82f-b52e-4092-b9dc-f2c9b0d6ab407
665040sitagliptin phosphate 25 MG Oral Tablet [Januvia]SBD1b03c82f-b52e-4092-b9dc-f2c9b0d6ab407
2709612sitagliptin phosphate 25 MG Oral TabletSCD1b03c82f-b52e-4092-b9dc-f2c9b0d6ab407
665040Januvia 25 MG (sitagliptin phosphate monohydrate 32.13 MG) Oral TabletSY1b03c82f-b52e-4092-b9dc-f2c9b0d6ab407
665040Januvia 25 MG Oral TabletSY1b03c82f-b52e-4092-b9dc-f2c9b0d6ab407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3527-05009035270090 TABLET, FILM COATED in 1 BOTTLE (50090-3527-0) 2018-08-010000-00-00NoNoCurrent
50090-3527-15009035270130 TABLET, FILM COATED in 1 BOTTLE (50090-3527-1) 2023-07-17NoNoHistorical