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 17 of 23 · 455 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDESaptalis Pharmaceuticals, LLC.df61d56e-18ff-404c-b671-42b39aa235742024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrasco Laboratorieseaf135b6-e378-4f62-a1e7-db45e23668c72024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack286d959a-51cb-4dbd-a3e8-1ea2f00b54c72024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.289dc8ec-42c8-1d09-e063-6394a90a97f02024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Lifesciences Limited5043d03e-3c9d-4c96-b48d-187f02a1d27c2024-12-05Exact identifier
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitedbd2e1c06-424b-4222-b723-90ffdcc3983c2024-11-30Exact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutions4ba2a76f-6665-4012-84e4-f2849a0246ac2024-11-27Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
MetforminMETFORMIN ER 750 MGBryant Ranch Prepackf1058475-1318-49a0-89ce-da06692b0e5b2024-11-25Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions565610b8-a9a0-4e5e-866d-81d9501a817d2024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2d2ebf52-3d5e-4fad-b7f7-c9280957574c2024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861004
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEOceanside Pharmaceuticals74d32a8a-c4c2-4dbb-b376-eea3f8fa64d72024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGProficient Rx LP92855c8d-59be-458b-97f1-2ff11b9bf6b02024-11-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
MetforminMETFORMIN ER 750 MGA-S Medication Solutions9e3791fb-9a34-4982-8164-0502fa398b012024-10-22Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 750 MGA-S Medication Solutions953404a4-0f03-42f1-8136-43238dad11f42024-10-22Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2bbaa0c-5b05-4335-882f-14f1b443edd72024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions54ca16e6-1213-4877-8ace-477c764c8e762024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861007
unii: 786Z46389E
Metformin HClMETFORMIN HCLNuCare Pharmaceuticals, Inc.242256af-c587-060a-e063-6294a90a68cc2024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC242538d7-fb79-4df6-e063-6394a90a5b962024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmerican Health Packagingdd54d30b-9390-4e5a-bf62-fbf18b91e4cd2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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