FDA.reportPublic FDA data

NDC 83301-0010-03 - 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
83301-0010
Requested NDC
83301-0010-03
Package NDCs from labels
83301-0010-1, 83301-0010-2, 83301-0010-3, 83301-0010-03
Manufacturer
Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.
Effective date
2025-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin HydrochlorideMullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.2025-10-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0010-1Metformin Hydrochloride100 in 1 BOTTLETABLET, COATED1006
83301-0010-2Metformin Hydrochloride500 in 1 BOTTLETABLET, COATED5006
83301-0010-3Metformin Hydrochloride1000 in 1 BOTTLETABLET, COATED10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0010METFORMIN HYDROCHLORIDE TABLET, COATED [MULLAN PHARMACEUTICAL INC.]4Current NDC, 3 package rows20240324_082b4de9-e452-fe71-e063-6394a90ac863.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0010-1EA - Each83301-001016a38516-a7c6-4f11-a655-118b462e675b12025-07-08
83301-0010-2EA - Each83301-0010307aab11-49de-46b6-830e-891e2824916412025-07-08
83301-0010-3EA - Each83301-001042878dc7-95f7-406b-9955-4ba3dccd61e312025-07-08

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 13 of 23 · 455 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPrecision Dose, Inc.37ff1b8e-a434-41c0-82e1-4583842921a52025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Sitagliptin and Metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEPar Health USA, LLC43e3b1c9-3cbd-8dc3-e063-6394a90a10a22025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutionsd43ccbc3-eb0b-400e-a6fa-31202dec3a712025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutions21cbb326-9dee-40ec-ac25-0dad79e3302b2025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutions397c2bf4-35be-4e75-b5a6-426e3fa095482025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.235680e6-1c3e-45b8-902e-866583f1aef32025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAvKARE1aa40000-877f-8ea4-e063-6394a90a0e312025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMullan Pharmaceutical Inc.082b4de9-e452-fe71-e063-6394a90ac8632025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
ndc (package): 83301-0008-1
ndc (package): 83301-0010-3
ndc (package): 83301-0009-3
ndc (package): 83301-0009-2
ndc (package): 83301-0010-1
ndc (package): 83301-0008-2
ndc (package): 83301-0010-2
ndc (package): 83301-0009-1
ndc (package): 83301-0008-3
ndc (product): 83301-0008
ndc (product): 83301-0009
ndc (product): 83301-0010
ndc11 (package): 83301001003
rxcui: 861007
rxcui: 861010
rxcui: 861004
spl id: 423f5f82-8524-65aa-e063-6294a90a1180
spl set id: 082b4de9-e452-fe71-e063-6394a90ac863
unii: 786Z46389E
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0230a3c3-34cf-478b-88c3-4d96e53000182025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.c72cfd1a-dce9-43a3-88e2-3cf1d9078b522025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEAvKARE13be49d2-0ce9-a78a-e557-ded85ddc808f2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.403349a1-ec19-8982-e063-6294a90aa0602025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4be72741-4f6d-6689-e054-00144ff8d46c2025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC3eeee3b7-188a-05a0-e063-6294a90a18532025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
MetforminMETFORMINCoupler LLC3edc9b51-ddee-61f8-e063-6294a90ad3c52025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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