FDA.reportPublic FDA data

NDC 0006-0575-01 - JANUMET

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
0006-0575
Requested NDC
0006-0575-01
Package NDCs from labels
0006-0575-82, 0006-0575-61, 0006-0575-62, 0006-0575-01, 0006-0575-52, 0006-0575-56, 0006-0575-02, 0006-0575-03
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JANUMET - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2026-08-11HUMAN PRESCRIPTION DRUG LABEL
JANUMET - A-S Medication SolutionsA-S Medication Solutions2026-07-09HUMAN PRESCRIPTION DRUG LABEL
JANUMET - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0575-01JANUMET10 in 1 BLISTER PACKTABLET, FILM COATED1060
0006-0575-02JANUMET14 in 1 BOTTLETABLET, FILM COATED1460
0006-0575-03JANUMET2 in 1 CARTONTABLET, FILM COATED260
0006-0575-52JANUMET5 in 1 CARTONTABLET, FILM COATED560
0006-0575-56JANUMET4 in 1 CARTONTABLET, FILM COATED460
0006-0575-56JANUMET2 in 1 POUCHTABLET, FILM COATED260
0006-0575-61JANUMET60 in 1 BOTTLETABLET, FILM COATED6060
0006-0575-62JANUMET180 in 1 BOTTLETABLET, FILM COATED18060
0006-0575-82JANUMET1000 in 1 BOTTLETABLET, FILM COATED100060

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0575JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]60Current NDC, Legacy NDC, 9 package rows20250331_d19c7ed0-ad5c-426e-b2df-722508f97d67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0575-03EA - Each0006-0575a2ffd725-a6f5-4ce9-a833-6ef93830770012018-04-19
0006-0575-52EA - Each0006-0575148c6394-4724-465d-92de-e1498cebe5d612012-07-24
0006-0575-61EA - Each0006-05759615799d-ea7d-4fdc-b6eb-4353ab4b33cd12012-07-24
0006-0575-62EA - Each0006-057556c54b0f-7c1c-4a66-9565-2211f98cc53a12012-07-24
0006-0575-82EA - Each0006-0575ebb3d102-c8bd-48ce-bd56-db57f9570b0512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
METFORMINACTIVE MOIETY9100L32L2NJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
TALCINACTIVE INGREDIENT7SEV7J4R1UJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33

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 125 · 2,489 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECardinal Health 107, LLC46cb7e3f-c739-433d-9dbe-427c2d95bef12026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
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
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEChartwell RX, LLC4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
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
Metformin ER 500 mgMETFORMIN ER 500 MGGranules India Ltdb857eccf-b9ff-45ba-8241-f47f5caada2a2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.13235d8e-ac3a-45b4-9c5d-9a9012951dfe2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.eeda90a0-4941-4716-8684-f9f12cbdf3af2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c82a10fa-1e8e-46b6-890a-737de3f34ee12026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5aa1c86c-f2c8-49b1-8f81-47b11386c5d32026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepackb5ccf5da-cbe1-4009-ba1c-990050838ee92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepacka086cc29-cb5d-40d0-a57d-8e91f1aa91582026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.fb890205-5d43-41eb-97b2-fb0dcdd3a9502026-07-13Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022044
rxcui: 2709488
rxcui: 861771
unii: TS63EW8X6F
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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