FDA.reportPublic FDA data

NDC 0006-0221-01 - JANUVIA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0006-0221
Requested NDC
0006-0221-01
Package NDCs from labels
0006-0221-01, 0006-0221-28, 0006-0221-31, 0006-0221-54
Manufacturer
A-S Medication Solutions
Effective date
2026-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JANUVIA - A-S Medication SolutionsA-S Medication Solutions2026-07-08HUMAN PRESCRIPTION DRUG LABEL
JANUVIA - A-S Medication SolutionsA-S Medication Solutions2026-07-08HUMAN PRESCRIPTION DRUG LABEL
JANUVIA - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2024-11-14HUMAN PRESCRIPTION DRUG LABEL
JANUVIA - A-S Medication SolutionsA-S Medication Solutions2023-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0221-01JANUVIA1 in 1 BLISTER PACKTABLET, FILM COATED171
0006-0221-28JANUVIA100 in 1 CARTONTABLET, FILM COATED10071
0006-0221-31JANUVIA30 in 1 BOTTLETABLET, FILM COATED3071
0006-0221-54JANUVIA90 in 1 BOTTLETABLET, FILM COATED9071

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0221JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]70Current NDC, Legacy NDC, 4 package rows20241122_f85a48d0-0407-4c50-b0fa-7673a160bf01.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0221-01EA - Each0006-0221d77b589c-4e42-4738-99ed-a098bf23cda612015-05-05
0006-0221-28EA - Each0006-0221f58e706e-5b35-4185-9df3-6a85b39ffb3412012-07-24
0006-0221-31EA - Each0006-0221f3cdd57d-c6bd-4929-9614-cbcc8d918cc412012-07-24
0006-0221-54EA - Each0006-02218f208ca9-1e7c-4dac-bc94-d17faf9950a612012-07-24

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 108 · 2,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: 532B59J990
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.