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 18 of 23 · 455 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0710e208-5b2c-3c72-e063-6394a90a4dac2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
Metformin HClMETFORMIN HCLAdvanced Rx of Tennessee, LLC21b76183-af30-e06f-e063-6394a90a96532024-09-23Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs23aa0072-365c-4d13-9aa7-ae23f7e00ee42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.d3a728a0-decb-4340-8ee4-c5e27c13eb192024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEWestminster Pharmaceuticals, LLC583dac53-65e7-4710-912a-ecd89d07ad032024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepacked6e6f87-ddd7-4c9d-a263-47154d3a94782024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGBryant Ranch Prepack1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc42024-08-26Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda07fa1d9-7171-4f2a-ab34-f8fa410364a62024-08-24Exact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5bb945c1-954a-4d43-aa24-33767d19c57c2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions011de1a5-1ac0-4831-9e8d-26ec79ba22052024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack6a9ab61a-a5d0-41ef-b528-59eac6b4cfe62024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda8a10ea0-7aa6-48ab-aad4-af88956366722024-08-16Exact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack32d6c5f4-0116-4e38-b179-e1967ae63e662024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4670d280-53c3-4c51-b3c5-26d71e47bddc2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.041632fa-9bf4-8d7c-e063-6294a90adefb2024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4a53ea53-3052-614b-e054-00144ff8d46c2024-07-19WarningsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1ef6c527-89f5-4830-8900-7532b0a7ef262024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEEpic Pharma, LLCa9e7608f-540c-d90c-e053-2a95a90a4f982024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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