JANUVIA

Product NDC
0006-0277
11-digit product format
000060277
Labeler code
0006
Product ID
0006-0277_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
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, 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
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
0006-0277-01JANUVIA1 in 1 BLISTER PACKTABLET, FILM COATED171
0006-0277-02JANUVIA30 in 1 DOSE PACKTABLET, FILM COATED3071
0006-0277-14JANUVIA7 in 1 BLISTER PACKTABLET, FILM COATED771
0006-0277-14JANUVIA2 in 1 CARTONTABLET, FILM COATED271
0006-0277-27JANUVIA4 in 1 CARTONTABLET, FILM COATED471
0006-0277-27JANUVIA7 in 1 BLISTER PACKTABLET, FILM COATED771
0006-0277-28JANUVIA100 in 1 CARTONTABLET, FILM COATED10071
0006-0277-30JANUVIA30 in 1 BOTTLETABLET, FILM COATED3071
0006-0277-31JANUVIA30 in 1 BOTTLETABLET, FILM COATED3071
0006-0277-33JANUVIA30 in 1 DOSE PACKTABLET, FILM COATED3071
0006-0277-54JANUVIA90 in 1 BOTTLETABLET, FILM COATED9071
0006-0277-82JANUVIA1000 in 1 BOTTLETABLET, FILM COATED100071

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0277-01EA - Each0006-0277230b9f72-0d13-4baa-86b7-fd197666f77512015-05-05
0006-0277-02EA - Each0006-0277f77fb2db-d3a8-4e18-8856-2b83a3408fa912015-06-09
0006-0277-28EA - Each0006-0277a1cd429c-a291-4da1-9f5d-33aea5062ada12012-07-24
0006-0277-31EA - Each0006-0277a866d79d-5562-43a9-976a-2250f876617812012-07-24
0006-0277-33EA - Each0006-0277fce65a4d-7645-40a0-a43b-9d522da72da212013-02-13
0006-0277-54EA - Each0006-02770f69965d-e473-4704-9ea6-ec462c66d59212012-07-24
0006-0277-82EA - Each0006-0277e49bafcd-2b35-43e0-8c66-f27b987e40bc12012-07-24

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 [PHYSICIANS TOTAL CARE, INC.]3
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]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 REDINACTIVE INGREDIENT1K09F3G675JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
polyvinyl alcoholINACTIVE INGREDIENT532B59J990JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]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
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
TALCINACTIVE INGREDIENT7SEV7J4R1UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
talcINACTIVE INGREDIENT7SEV7J4R1UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]3
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
magnesium stearateINACTIVE INGREDIENT70097M6I30JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
talcINACTIVE INGREDIENT7SEV7J4R1UJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPJANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0277JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]70Current NDC, Legacy NDC, 12 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
665036Januvia 100 MG Oral TabletPSN9d558f96-24a5-4788-8933-38256c17384b15
2709603SITagliptin phosphate 100 MG Oral TabletPSN9d558f96-24a5-4788-8933-38256c17384b15
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBD9d558f96-24a5-4788-8933-38256c17384b15
2709603sitagliptin phosphate 100 MG Oral TabletSCD9d558f96-24a5-4788-8933-38256c17384b15
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSY9d558f96-24a5-4788-8933-38256c17384b15
665036Januvia 100 MG Oral TabletPSNe2e576e6-6181-4178-b989-61d0e795e55913
2709603SITagliptin phosphate 100 MG Oral TabletPSNe2e576e6-6181-4178-b989-61d0e795e55913
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBDe2e576e6-6181-4178-b989-61d0e795e55913
2709603sitagliptin phosphate 100 MG Oral TabletSCDe2e576e6-6181-4178-b989-61d0e795e55913
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSYe2e576e6-6181-4178-b989-61d0e795e55913
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
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
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
665036Januvia 100 MG Oral TabletPSN963792a9-4029-4e7b-9759-9ad52e1b09621
2709603SITagliptin phosphate 100 MG Oral TabletPSN963792a9-4029-4e7b-9759-9ad52e1b09621
665036sitagliptin phosphate 100 MG Oral Tablet [Januvia]SBD963792a9-4029-4e7b-9759-9ad52e1b09621
2709603sitagliptin phosphate 100 MG Oral TabletSCD963792a9-4029-4e7b-9759-9ad52e1b09621
665036Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral TabletSY963792a9-4029-4e7b-9759-9ad52e1b09621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0277-01000060277011 in 1 BLISTER PACKHistorical
0006-0277-020000602770230 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-02) 2006-10-160000-00-00NoNoCurrent
0006-0277-14000060277142 BLISTER PACK in 1 CARTON (0006-0277-14) / 7 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2012-10-120000-00-00NoNoCurrent
0006-0277-27000060277274 in 1 CARTONHistorical
0006-0277-2800006027728100 BLISTER PACK in 1 CARTON (0006-0277-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0277-01) 100 blister pack2006-10-160000-00-00NoNoCurrent
0006-0277-300000602773030 in 1 BOTTLEHistorical
0006-0277-310000602773130 TABLET, FILM COATED in 1 BOTTLE (0006-0277-31) 2006-10-160000-00-00NoNoCurrent
0006-0277-330000602773330 TABLET, FILM COATED in 1 DOSE PACK (0006-0277-33) 2006-10-160000-00-00NoNoCurrent
0006-0277-540000602775490 TABLET, FILM COATED in 1 BOTTLE (0006-0277-54) 2006-10-160000-00-00NoNoCurrent
0006-0277-82000060277821000 TABLET, FILM COATED in 1 BOTTLE (0006-0277-82) 2006-10-160000-00-00NoNoCurrent