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 3 of 155 · 3,089 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jentadueto XRLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.3d02a4d4-d312-80b4-05c4-691b8f0aa7aa2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack4dcef36f-000e-43f5-8d67-0e2a079ab2c62026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLUnit Dose Solutions, Inc.5538e9df-0983-9281-e063-6394a90a92492026-08-18Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
KAZANOALOGLIPTIN AND METFORMIN HYDROCHLORIDETakeda Pharmaceuticals America, Inc.83cb7914-a683-47bb-a713-f2bc6a596bd22026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.58f0e875-5d9b-be0b-e063-6394a90a53452026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC25be863d-490c-47f6-9ad3-c828dc43fbf02026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited0098dec4-f0e5-45d5-8aa4-5d0faf9ab1422026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
SEGLUROMETERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCa6aeb99a-ce49-4125-90ce-642df3f1ebad2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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