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 24 of 25 · 482 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd51f3618-4166-4925-8994-968a653ebc462022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd80aa4af-a8ce-4cae-b71c-05e1de8295512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP5f243894-bda3-4fa9-97e4-209dcb389dee2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSScieGen Pharmaceuticals, Inc.16dc4008-7b5e-4c6d-9bc8-8db96be911a12022-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP738402d6-3700-46b2-a90c-2e8f2c354a392022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc789254c-be70-4d25-8c6c-b284b01eb5132022-02-22Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5e5fb10b-b874-43c9-9424-9080b9e866c82022-02-22Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC0b843f12-a654-4751-be1f-55e6fce163c92021-12-08WarningsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLBryant Ranch Prepack1f8833f9-1232-4aa7-a0d4-04a9f87dc2f02021-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861010
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1e298db3-439e-4e91-8f9e-01c3cdc4d5522021-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d89a4ab-6cdd-4c39-92f9-a137fa27a0702021-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSScieGen Pharmaceuticals, Inc.1452fbb1-e591-4a51-9f83-8a8a6a780b522021-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC439bb230-94d8-4522-ad79-5cce5fad965b2021-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9632456f-57c2-444b-9f43-d9ca862681fe2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861010
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEACI Healthcare USA, Inc.e18b60f9-721e-4db6-9f61-d3437e18faf22020-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEEpic Pharma, LLC8c1848f9-c113-4552-b6ef-715e72630ad92019-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090564
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP6f6118c1-cecc-4d7b-9965-7b114a1ad56b2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HClGLIPIZIDE AND METFORMIN HCLProficient Rx LPbe4d2552-c964-4d09-ba7a-0d94320f968c2019-10-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals5c2581e3-2b30-4da5-8bed-228173ca20d22019-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861007
rxcui: 861010
rxcui: 861004
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals LLCc01a79e0-f2b7-4d99-857e-bda7f24fe3192018-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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