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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.a63364d5-4dfa-49d7-8a5e-c8959ae1d37a2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Limitede98b2abd-8068-482e-9ce3-1ab262f0838e2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEGolden State Medical Supply, Inc.6f14ced9-c16b-905a-e053-2a91aa0a031e2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATESafecor Health LLCf177e6fa-c482-432d-8208-937468ab3f102026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAvPAK4992fdaa-b880-ee25-e063-6394a90af03b2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
MethotrexateMETHOTREXATEChartwell RX, LLC2609da8f-80dc-448e-8eba-35d11488ce7f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210454
rxcui: 105585
unii: 3IG1E710ZN
RasuvoMETHOTREXATEMedexus Pharma Inc.d0075461-0e7e-4967-9c9b-d6440e912c0e2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEHospira, Inc.0e30eaef-5a09-4104-8a11-c32933eadeab2025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCec476b11-0b3c-4139-b1eb-a3daa76bc2712025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEMylan Institutional Inc.8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATETeva Parenteral Medicines, Inc.346ec9ce-dc98-4a55-b55e-d3af11f2d7032025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEEugia US LLC63bb6fbf-dd59-4edc-af8f-d0c397ca12622025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEHospira, Inc.bd287e89-32f9-4396-95fa-4b562869f4762025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEHospira, Inc.0d63ba29-b692-41b4-87e8-351265c8273f2025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATECoupler LLC2f20d43e-a4b3-a839-e063-6394a90ace382025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATENuCare Pharmaceuticals, Inc.2b61822e-b488-5eaf-e063-6394a90a2dcd2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210454
ndc (package): 68071-3765-6
ndc (package): 68071-3765-9
ndc (product): 68071-3765
ndc11 (package): 68071376506
rxcui: 105585
spl id: 2bae0372-8ccb-0028-e063-6294a90a889f
spl set id: 2b61822e-b488-5eaf-e063-6394a90a2dcd
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEZydus Lifesciences Limited59ea7b32-2b6d-4197-92c3-015936f04ebe2024-12-05Exact identifier
rxcui: 105585
MethotrexateMETHOTREXATEBryant Ranch Prepacke6611304-4622-4b2e-9b94-57fbad023ae22024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN

Reported adverse events (FAERS/openFDA)#

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