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 17 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA090564
rxcui: 861007
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEProficient Rx LPf1530d4f-21d9-4a4f-a814-07b180828ecd2025-02-01WarningsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP7cb47c3e-6657-4c11-8aa2-ae172e5a85292025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDELifsa Drugs, LLCa2385bcd-0943-4411-8658-c22b503603852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDERedPharm Drug, Inc.fc61bafa-a506-14ae-e053-6394a90a9c7d2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEdirect rxa84cf1a3-3820-cd1b-e053-2995a90acf452025-01-22WarningsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4adeddf2-f449-4a61-9658-dfbff7c502302025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC27d6fdbc-27a8-c599-e063-6394a90a22332025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.0f251f2c-97f3-4048-84f2-81fea03685aa2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGA-S Medication Solutionsfdd3481c-aaec-47ac-9790-01de68b2e2532025-01-09Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: B697894SGQ
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDETRUPHARMA, LLC73691c6c-8841-4c5d-b4a5-c3ed3b5effa12024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
unii: B697894SGQ
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

Reported adverse events (FAERS/openFDA)#

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