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 19 of 25 · 493 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
Metformin HClMETFORMIN HCLAdvanced Rx of Tennessee, LLC21b76183-af30-e06f-e063-6394a90a96532024-09-23Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
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
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: B697894SGQ
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
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
application number: ANDA090564
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
application number: ANDA090564
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
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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