FDA.reportPublic FDA data

JANUVIA

Product NDC
0006-0112
11-digit product format
000060112
Labeler code
0006
Product ID
0006-0112_71d449de-955b-4711-9a44-1e1f66e2e9eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sitagliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA021995
Marketing category
NDA
Marketing start
2006-10-16
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
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 PHOSPHATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTS63EW8X6F
Rxcui665036, 665040, 665044, 2709603, 2709608, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0112-01JANUVIA1 in 1 BLISTER PACKTABLET, FILM COATED171
0006-0112-28JANUVIA100 in 1 CARTONTABLET, FILM COATED10071
0006-0112-31JANUVIA30 in 1 BOTTLETABLET, FILM COATED3071
0006-0112-54JANUVIA90 in 1 BOTTLETABLET, FILM COATED9071

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0112-01EA - Each0006-011248407127-b69a-46e5-abb7-f4d2eacd80a312015-12-02
0006-0112-28EA - Each0006-01127d7e84b0-b6c2-4e9f-a5e3-36a082b407bf12012-07-24
0006-0112-31EA - Each0006-0112500cbbe5-5ddf-41ae-92a7-a61953371d8412012-07-24
0006-0112-54EA - Each0006-01121752c6bc-dca7-4c39-a548-c534d1ab9a6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
polyvinyl alcoholINACTIVE INGREDIENT532B59J990JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
talcINACTIVE INGREDIENT7SEV7J4R1UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]45
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
magnesium stearateINACTIVE INGREDIENT70097M6I30JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
polyvinyl alcoholINACTIVE INGREDIENT532B59J990JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
talcINACTIVE INGREDIENT7SEV7J4R1UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]11
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0112JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]70Current NDC, Legacy NDC, 4 package rows20241122_f85a48d0-0407-4c50-b0fa-7673a160bf01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665036Januvia 100 MG Oral TabletPSNf85a48d0-0407-4c50-b0fa-7673a160bf0171
665040Januvia 25 MG Oral TabletPSNf85a48d0-0407-4c50-b0fa-7673a160bf0171
665044Januvia 50 MG Oral TabletPSNf85a48d0-0407-4c50-b0fa-7673a160bf0171
2709603SITagliptin phosphate 100 MG Oral TabletPSNf85a48d0-0407-4c50-b0fa-7673a160bf0171
2709612SITagliptin phosphate 25 MG Oral TabletPSNf85a48d0-0407-4c50-b0fa-7673a160bf0171
2709608SITagliptin phosphate 50 MG Oral TabletPSNf85a48d0-0407-4c50-b0fa-7673a160bf0171
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBDf85a48d0-0407-4c50-b0fa-7673a160bf0171
665040sitagliptin phosphate 25 MG Oral Tablet [Januvia]SBDf85a48d0-0407-4c50-b0fa-7673a160bf0171
665044sitagliptin phosphate 50 MG Oral Tablet [Januvia]SBDf85a48d0-0407-4c50-b0fa-7673a160bf0171
2709603sitagliptin phosphate 100 MG Oral TabletSCDf85a48d0-0407-4c50-b0fa-7673a160bf0171
2709612sitagliptin phosphate 25 MG Oral TabletSCDf85a48d0-0407-4c50-b0fa-7673a160bf0171
2709608sitagliptin phosphate 50 MG Oral TabletSCDf85a48d0-0407-4c50-b0fa-7673a160bf0171
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSYf85a48d0-0407-4c50-b0fa-7673a160bf0171
665040Januvia 25 MG (sitagliptin phosphate monohydrate 32.13 MG) Oral TabletSYf85a48d0-0407-4c50-b0fa-7673a160bf0171
665040Januvia 25 MG Oral TabletSYf85a48d0-0407-4c50-b0fa-7673a160bf0171
665044Januvia 50 MG (as sitagliptin phosphate monohydrate 64.25 MG) Oral TabletSYf85a48d0-0407-4c50-b0fa-7673a160bf0171
665044Januvia 50 MG Oral TabletSYf85a48d0-0407-4c50-b0fa-7673a160bf0171
665044Januvia 50 MG Oral TabletPSN39253ddd-0245-43b1-ad28-d5923983afb426
2709608SITagliptin phosphate 50 MG Oral TabletPSN39253ddd-0245-43b1-ad28-d5923983afb426
665044sitagliptin phosphate 50 MG Oral Tablet [Januvia]SBD39253ddd-0245-43b1-ad28-d5923983afb426
2709608sitagliptin phosphate 50 MG Oral TabletSCD39253ddd-0245-43b1-ad28-d5923983afb426
665044Januvia 50 MG (as sitagliptin phosphate monohydrate 64.25 MG) Oral TabletSY39253ddd-0245-43b1-ad28-d5923983afb426
665044Januvia 50 MG Oral TabletSY39253ddd-0245-43b1-ad28-d5923983afb426
665044Januvia 50 MG Oral TabletPSN194c3718-5eb5-4cf5-85d0-2bb1ed8293b811
2709608SITagliptin phosphate 50 MG Oral TabletPSN194c3718-5eb5-4cf5-85d0-2bb1ed8293b811
665044sitagliptin phosphate 50 MG Oral Tablet [Januvia]SBD194c3718-5eb5-4cf5-85d0-2bb1ed8293b811
2709608sitagliptin phosphate 50 MG Oral TabletSCD194c3718-5eb5-4cf5-85d0-2bb1ed8293b811
665044Januvia 50 MG (as sitagliptin phosphate monohydrate 64.25 MG) Oral TabletSY194c3718-5eb5-4cf5-85d0-2bb1ed8293b811
665044Januvia 50 MG Oral TabletSY194c3718-5eb5-4cf5-85d0-2bb1ed8293b811
665044Januvia 50 MG Oral TabletPSNeb81a45f-05b8-49de-99ce-5089bd360d9b8
2709608SITagliptin phosphate 50 MG Oral TabletPSNeb81a45f-05b8-49de-99ce-5089bd360d9b8
665044sitagliptin phosphate 50 MG Oral Tablet [Januvia]SBDeb81a45f-05b8-49de-99ce-5089bd360d9b8
2709608sitagliptin phosphate 50 MG Oral TabletSCDeb81a45f-05b8-49de-99ce-5089bd360d9b8
665044Januvia 50 MG (as sitagliptin phosphate monohydrate 64.25 MG) Oral TabletSYeb81a45f-05b8-49de-99ce-5089bd360d9b8
665044Januvia 50 MG Oral TabletSYeb81a45f-05b8-49de-99ce-5089bd360d9b8
665036Januvia 100 MG Oral TabletPSNaaadccea-4842-493b-a0bd-0ee7645fc2503
665044Januvia 50 MG Oral TabletPSNaaadccea-4842-493b-a0bd-0ee7645fc2503
2709603SITagliptin phosphate 100 MG Oral TabletPSNaaadccea-4842-493b-a0bd-0ee7645fc2503
2709608SITagliptin phosphate 50 MG Oral TabletPSNaaadccea-4842-493b-a0bd-0ee7645fc2503
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBDaaadccea-4842-493b-a0bd-0ee7645fc2503
665044sitagliptin phosphate 50 MG Oral Tablet [Januvia]SBDaaadccea-4842-493b-a0bd-0ee7645fc2503
2709603sitagliptin phosphate 100 MG Oral TabletSCDaaadccea-4842-493b-a0bd-0ee7645fc2503
2709608sitagliptin phosphate 50 MG Oral TabletSCDaaadccea-4842-493b-a0bd-0ee7645fc2503
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSYaaadccea-4842-493b-a0bd-0ee7645fc2503
665044Januvia 50 MG (as sitagliptin phosphate monohydrate 64.25 MG) Oral TabletSYaaadccea-4842-493b-a0bd-0ee7645fc2503
665044Januvia 50 MG Oral TabletSYaaadccea-4842-493b-a0bd-0ee7645fc2503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0112-01000060112011 in 1 BLISTER PACKHistorical
0006-0112-2800006011228100 BLISTER PACK in 1 CARTON (0006-0112-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01) 100 blister pack2006-10-160000-00-00NoNoCurrent
0006-0112-310000601123130 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31) 2006-10-160000-00-00NoNoCurrent
0006-0112-540000601125490 TABLET, FILM COATED in 1 BOTTLE (0006-0112-54) 2006-10-160000-00-00NoNoCurrent