METHOTREXATE SODIUM - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2018-11-20
Label type: Indexing - product concept
Version: 1
Source: full-release
Hydrated at: 2026-06-05 00:17:56

Label at a glance#

ProductMETHOTREXATE SODIUM

Active ingredientMETHOTREXATE SODIUM

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

METHOTREXATE SODIUM
METHOTREXATE

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METHOTREXATE SODIUM	3IG1E710ZN	ACTIM

Source Document#

Source XML

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate Sodium	METHOTREXATE SODIUM	Elite Laboratories, Inc.	89c05ea3-3be1-46dd-b112-29c436fd7289	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate Sodium generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Sun Pharmaceutical Industries, Inc.	8f1260de-b60c-4f0e-8af6-0e957b0a281b	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate Sodium	METHOTREXATE SODIUM	Hikma Pharmaceuticals USA Inc.	d71b1856-99d8-4a9e-9189-f87b6675f80a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate Sodium generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ec476b11-0b3c-4139-b1eb-a3daa76bc271	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Bryant Ranch Prepack	c7592288-ac24-46c6-8cec-9abe23d7e81e	2023-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	b585f621-f6c9-4735-ab61-bd1b401f3df0	2021-03-24	Boxed warning, Adverse reactions	Name fallback generic name: METHOTREXATE SODIUM

Reported adverse events (FAERS/openFDA)#

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