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 11 of 125 · 2,489 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
Metformin HClMETFORMIN HCLProficient Rx LPd2c927eb-12bf-4c7d-9ef5-0036b2dd8c292026-06-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d1d7204a-7e8a-4f76-bf9f-3e798c2632ba2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEWestminster Pharmaceuticals, LLC836f3647-bfef-40d1-b475-c0d240241a672026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 15FIX9V2JP
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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