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 76 of 155 · 3,089 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Metformin HClMETFORMIN HCLA-S Medication Solutions397c2bf4-35be-4e75-b5a6-426e3fa095482025-11-06Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7163861-7084-5adf-e053-2995a90ae1992025-11-04WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b71619c4-a8ef-1dda-e053-2995a90aba502025-11-04WarningsExact identifier
unii: 15FIX9V2JP
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.235680e6-1c3e-45b8-902e-866583f1aef32025-11-04Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAvKARE1aa40000-877f-8ea4-e063-6394a90a0e312025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 860975
unii: 786Z46389E
Land Shark SPF 40ZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d204c38c-b5d1-3511-e053-2a95a90a9dc82025-11-04WarningsExact identifier
unii: 15FIX9V2JP
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
unii: 15FIX9V2JP
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
unii: 15FIX9V2JP
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
unii: 15FIX9V2JP
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
unii: 15FIX9V2JP
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bc865f-29bd-da90-e063-6294a90aa16d2025-11-03WarningsExact identifier
unii: 15FIX9V2JP
Biopo Facial Mineral Sunscreen- Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bd8bce-2959-266a-e063-6394a90a9a412025-11-03WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 205 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.055878ef-c671-4d65-9639-bda5a1dc30292025-10-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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