FDA.reportPublic FDA data

NDC 0006-0577-02 - 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
0006-0577
Requested NDC
0006-0577-02
Package NDCs from labels
0006-0577-61, 0006-0577-62, 0006-0577-82, 0006-0577-01, 0006-0577-52, 0006-0577-56, 0006-0577-02, 0006-0577-03
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 Solutions2026-07-13HUMAN PRESCRIPTION DRUG LABEL
JANUMET - A-S Medication SolutionsA-S Medication Solutions2023-06-19HUMAN PRESCRIPTION DRUG LABEL
JANUMET - REMEDYREPACK INC.REMEDYREPACK INC.2022-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0577-01JANUMET10 in 1 BLISTER PACKTABLET, FILM COATED1060
0006-0577-02JANUMET14 in 1 BOTTLETABLET, FILM COATED1460
0006-0577-03JANUMET2 in 1 CARTONTABLET, FILM COATED260
0006-0577-52JANUMET5 in 1 CARTONTABLET, FILM COATED560
0006-0577-56JANUMET4 in 1 CARTONTABLET, FILM COATED460
0006-0577-56JANUMET2 in 1 POUCHTABLET, FILM COATED260
0006-0577-61JANUMET60 in 1 BOTTLETABLET, FILM COATED6060
0006-0577-62JANUMET180 in 1 BOTTLETABLET, FILM COATED18060
0006-0577-82JANUMET1000 in 1 BOTTLETABLET, FILM COATED100060

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0577JANUMET (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
0006-0577-52EA - Each0006-0577a4716ea6-e7f4-4a28-b5ef-02465a7044fe12012-07-24
0006-0577-61EA - Each0006-057780e8870b-a7a8-4bd9-87f7-e5da286c795512012-07-24
0006-0577-62EA - Each0006-0577eb2a5069-b1e7-4ba6-a7d1-231821740fbc12012-07-24
0006-0577-82EA - Each0006-057768dd2276-9231-4ddf-8208-beb5c89832a512012-07-24

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 1 of 126 · 2,516 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.d5228e81-9c86-4781-b984-20feaa2ae7792026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGREMEDYREPACK INC.05999192-ebc6-4198-bd1e-f46abbfb4f8a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECamber Pharmaceuticals, Inc.7cc02a26-5c22-445b-ad8f-3e7570c143d32026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGranules India Ltd73197cb5-3e23-4ac0-b189-f9bc848bce662026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsb6d7edc9-93d6-4480-906d-55c18d0536002026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited1fa2703e-fb73-44d5-aaa2-b12b1090d42c2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone HCL and Metformin HCLPIOGLITAZONE HCL AND METFORMIN HCLTorrent Pharmaceuticals Limited237d8fa2-633c-4c29-84d3-f1b413610dc32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions64f5b140-7ad8-4c07-bbfc-ae4618afa8502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.c568d49f-c040-4f1e-ad36-77b05ab659c32026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba0379cb-824e-4798-9ff9-99bcd1bea5cb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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