FDA.reportPublic FDA data

NDC 48433-326-01 - Metformin Hydrochloride

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
48433-326
Requested NDC
48433-326-01
Package NDCs from labels
48433-326-01, 48433-326-10
Manufacturer
Safecor Health, LLC
Effective date
2013-09-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride - Safecor Health, LLCSafecor Health, LLC2013-09-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48433-326-102020-01-31C16284748780-19d75b9d1-153c-f424-e053-dadaa90a57ceMETFORMIN HYDROCHLORIDE TABLETS USP, 500 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-326-01Metformin Hydrochloride1 in 1 POUCHTABLET, FILM COATED11
48433-326-10Metformin Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-326METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1Legacy NDC, 2 package rows20141014_14f29eeb-4db9-47be-a981-1e9f400a2139.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC]1

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 155 · 3,089 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf4fc759a-057e-4b5d-b8ab-13bc5eeb24e42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions400ff9dc-9789-44ac-afb5-730b632a16672026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
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
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc0ff557c-fa50-46f6-aa77-36a4df354e802026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions4f5389d2-dbcf-4fcb-9048-05953eb1fb052026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
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
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4d245bc3-0add-4651-b441-86b93c5ac6812026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.03d9ce02-0559-494c-a53d-de9b9a64b6062026-06-11Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.2239742b-74e1-4bc2-b5a8-15c4758d6f7b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC53e950f5-c58f-78e3-e063-6294a90a53e92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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