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 13 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: B697894SGQ
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: B697894SGQ
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC0ff1ba75-3c86-4baf-a6b1-1bb8838398662025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b63bfafa-db4c-4fb8-84cd-ff73a5e7d3202025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: B697894SGQ
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsfaa19e1b-2782-4bf1-a93f-84755f7aa53f2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and metformin hclGLIPIZIDE AND METFORMIN HCLChartwell RX, LLCac018f64-fd9d-4b3c-b0ac-ca305b8df6352025-12-10Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutionsc37b511c-1e33-4941-bd12-df0447a50ca92025-12-06Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861010
unii: 786Z46389E
Metformin HClMETFORMIN HCLQPharma, Inc.06ade2e1-5981-4e3d-b7e9-7ff083eb45512025-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE TABLETQuallent Pharmaceuticals Health LLCf39ee08d-73db-71b9-e053-2995a90a877c2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
rxcui: 861004
unii: 786Z46389E
Metformin ER 500 mgMETFORMIN ER 500 MGQuallent Pharmaceuticals Health LLCff196435-14f4-8b9d-e053-6294a90a4ee82025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone and metformin hydrochloridePIOGLITAZONE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack86ca843a-441b-488d-be1d-2576aeee19cf2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone and metformin hydrochloridePIOGLITAZONE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack8080eedb-e955-4059-98b2-9685b608eb3e2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPrecision Dose, Inc.37ff1b8e-a434-41c0-82e1-4583842921a52025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Sitagliptin and Metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEPar Health USA, LLC43e3b1c9-3cbd-8dc3-e063-6394a90a10a22025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutionsd43ccbc3-eb0b-400e-a6fa-31202dec3a712025-11-10Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutions21cbb326-9dee-40ec-ac25-0dad79e3302b2025-11-07Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutions397c2bf4-35be-4e75-b5a6-426e3fa095482025-11-06Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.235680e6-1c3e-45b8-902e-866583f1aef32025-11-04Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAvKARE1aa40000-877f-8ea4-e063-6394a90a0e312025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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