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 68 of 155 · 3,089 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
unii: 15FIX9V2JP
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
unii: 15FIX9V2JP
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
unii: 15FIX9V2JP
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
unii: 15FIX9V2JP
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
unii: 15FIX9V2JP
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
unii: 15FIX9V2JP
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
unii: 15FIX9V2JP
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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