FDA.reportPublic FDA data

NDC 83301-0010-01 - 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
83301-0010
Requested NDC
83301-0010-01
Package NDCs from labels
83301-0010-1, 83301-0010-2, 83301-0010-3, 83301-0010-01
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 16 of 24 · 468 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack52eecdbd-e07e-447f-bf38-b3c347b606622025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazole and metformin hydrochloridePIOGLITAZOLE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack7418254e-7232-466f-9d6b-4743b0bba2a12025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazole and metformin hydrochloridePIOGLITAZOLE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepackbd9c05c9-278f-498d-881c-29ba1b60596e2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECoupler LLC33ec9f6e-16d9-40ba-e063-6294a90ae87b2025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMINCoupler LLC33ecddbe-860a-6ca8-e063-6294a90aac642025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.103080cb-6381-44f6-8a31-1fc81e7c890f2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.33155746-c2ef-12f4-e063-6294a90a039c2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDETAGI Pharma, Inc.dd0ee2bf-f658-42dc-976d-49af0b1f32b52025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler, LLC32ff33ed-89ed-c391-e063-6294a90ae4142025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205096
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackd7c1ff9e-4faa-4f65-9c87-e8108499791f2025-03-28WarningsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack3e55944a-ed5b-4892-804f-abbe15b0d70c2025-03-28WarningsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackde4a660b-172b-4c72-9e38-5634fd03cfa72025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.8d252dab-e868-42d3-95ea-69423d909e842025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Metformin HClMETFORMIN HCLTIME CAP LABORATORIES, INC542cec22-eeae-4704-9bb6-4176640e5ea82025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECoupler LLC2d7d9364-e71d-4ef6-e063-6394a90af8412025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4db5551b-04f6-4921-9dee-68acb41f7f712025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0865f83f-0f34-0690-e063-6294a90abf042025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b3d5420-d60c-8385-e063-6394a90abb6c2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Metformin HClMETFORMIN HCLNuCare Pharmaceuticals,Inc.0b3d7c79-9a5a-a82e-e063-6394a90a3caa2025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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