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 5 of 108 · 2,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
STEGLUJANERTUGLIFLOZIN AND SITAGLIPTINMerck Sharp & Dohme LLCc2c553d8-5a9d-4366-bf53-8bdb5a876d192026-06-03Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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