FDA.reportPublic FDA data

NDC 16729-486-36 - 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
16729-486
Requested NDC
16729-486-36
Package NDCs from labels
16729-486-36, 16729-486-01
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methotrexate - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2026-05-27HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - Bryant Ranch PrepackBryant Ranch Prepack2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2026-04-30HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - Coupler LLCCoupler LLC2025-02-27HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - Proficient Rx LPProficient Rx LP2024-08-01HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-486-01Methotrexate100 in 1 BOTTLETABLET1008
16729-486-36Methotrexate36 in 1 BOTTLETABLET368

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-486METHOTREXATE TABLET [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 2 package rows20231203_874c7f43-a3be-4236-89cc-24c44e3c5813.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 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2357252a-b7fc-4192-e063-6394a90abe8e912e2a80-bb07-457f-8944-d9f672ef80812024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 912e2a80-bb07-457f-8944-d9f672ef8081
MethotrexateMETHOTREXATEProficient Rx LPa76808f0-38a7-4b54-a4fb-3584f9058ae52024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA213343
ndc (package): 82804-136-30
ndc (product): 82804-136
rxcui: 105585
spl id: a76808f0-38a7-4b54-a4fb-3584f9058ae5
spl set id: a76808f0-38a7-4b54-a4fb-3584f9058ae5
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.