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 3 of 108 · 2,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutions62c4f58b-2b28-4825-aeb6-213ab9b7a0262026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 2709603
rxcui: 665036
unii: TS63EW8X6F
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
JANUVIASITAGLIPTINA-S Medication Solutions194c3718-5eb5-4cf5-85d0-2bb1ed8293b82026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 665044
rxcui: 2709608
unii: TS63EW8X6F
618eaf11-4288-4c4f-95ed-53112029bf7692829830-b869-4ec8-b498-73f5b2e8e7be2026-07-08Warnings, Adverse reactionsExact identifier
spl set id: 92829830-b869-4ec8-b498-73f5b2e8e7be
JANUVIASITAGLIPTINA-S Medication Solutions4a758211-8af1-449b-9a10-f3d67d7ec8b62026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
ndc (package): 50090-4087-0
ndc (product): 50090-4087
rxcui: 665040
rxcui: 2709612
spl id: 97b5b77b-766b-4f55-b7f8-21a0214e6ee5
spl set id: 4a758211-8af1-449b-9a10-f3d67d7ec8b6
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutions1b03c82f-b52e-4092-b9dc-f2c9b0d6ab402026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
ndc (package): 50090-3527-1
ndc (package): 50090-3527-0
ndc (product): 50090-3527
rxcui: 665040
rxcui: 2709612
spl id: a8fb9fdc-d34e-45db-8ecf-f9de43c069ad
spl set id: 1b03c82f-b52e-4092-b9dc-f2c9b0d6ab40
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutionseb81a45f-05b8-49de-99ce-5089bd360d9b2026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 665044
rxcui: 2709608
unii: TS63EW8X6F
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
unii: 532B59J990
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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