FDA.reportPublic FDA data

NDC 68071-3697-01 - Metformin HCl

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
68071-3697
Requested NDC
68071-3697-01
Package NDCs from labels
68071-3697-1, 68071-3697-01
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2024-10-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metformin Hydrochloride Tablets USPNuCare Pharmaceuticals, Inc.2024-10-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3697-1Metformin HCl100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3697METFORMIN HCL TABLET [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20241012_242256af-c587-060a-e063-6294a90a68cc.zip

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 5 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE TABLETGranules India Ltd8cd5555c-f6b2-28d8-e053-2a95a90a5f1e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.1b18b903-eb52-4d08-b4a5-f984957eb1162026-06-27Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEUnit Dose Solutions, Inc.552ad61d-bafd-478d-e063-6294a90a02f92026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLUnit Dose Solutions, Inc.552df462-6dcb-e6f2-e063-6294a90aacfe2026-06-26Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEMarlex Pharmaceuticals, Inc.3d6f397b-e909-bee9-e063-6294a90aba172026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HClGLIPIZIDE AND METFORMIN HCLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.94a7f96e-2ed1-432d-bc6a-5840863816e12026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEViona Pharmaceuticals Inc85027e6c-d35b-49eb-a234-dd71aa77aee02026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSAiPing Pharmaceutical, Inc.96c8a89d-99db-24b1-e053-2a95a90ac2b82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.41a8bb80-7b0b-476c-8134-5d161c3239c82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited8d4b8620-5e99-4d12-b4f2-e9967b627b572026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMajor Pharmaceuticals5e783025-bf6d-465e-bf58-bcd253afad2c2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4182bcf0-1f9a-4f3a-9428-86b5d757954f2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c32026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.14450912-54b5-4fc3-ba65-77ece864b2e72026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.902d1bc4-3f1f-4a1a-86d7-cf98c56a36842026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861010
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.33550b88-d4bb-4ce6-a7db-07c966f6984f2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc.14238afd-200d-4a05-b731-647c43cecbc32026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.104b5f5b-cc83-450d-82ec-1fd20c4f71192026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack11d52559-bfde-4c2a-9602-f18fb31876172026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGCoupler LLC54620ea3-da64-c5d7-e063-6394a90ad14a2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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