FDA.reportPublic FDA data

NDC 68071-3765-06 - Methotrexate

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
68071-3765
Requested NDC
68071-3765-06
Package NDCs from labels
68071-3765-9, 68071-3765-6, 68071-3765-06
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2025-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methotrexate - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2025-01-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3765-6Methotrexate60 in 1 BOTTLETABLET602
68071-3765-9Methotrexate90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3765METHOTREXATE TABLET [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250116_2b61822e-b488-5eaf-e063-6394a90a2dcd.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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEProficient Rx LPa76808f0-38a7-4b54-a4fb-3584f9058ae52024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Limitedff55c573-dc84-4ff3-9d10-2b24c47dd6792024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
MethotrexateMETHOTREXATE SODIUMBryant Ranch Prepackc7592288-ac24-46c6-8cec-9abe23d7e81e2023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCb585f621-f6c9-4735-ab61-bd1b401f3df02021-03-24Boxed warning, Adverse reactionsExact identifier
unii: 3IG1E710ZN

Reported adverse events (FAERS/openFDA)#

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