Methotrexate

Basic Information

Product Name

Methotrexate

FDA Product Code

71335-1118

Regulatory Information

NDC Product Code

71335-1118

Application Number

ANDA081235

Marketing Category

C73584

Effective Date

June 29, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral useInitial U.S. Approval: 1953

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 101

Code: 7T9FYH5QMK

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SODIUM CARBONATE MONOHYDRATE

Code: 2A1Q1Q3557

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

METHOTREXATE SODIUM

Quantity: 2.5 mg in 1 1

Code: 3IG1E710ZN

Class Code: ACTIM

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

Code: YL5FZ2Y5U1

Methotrexate

Basic Information

Regulatory Information

Company Information

Active Ingredients

SILICON DIOXIDE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE 101

STARCH, CORN

SODIUM LAURYL SULFATE

SODIUM CARBONATE MONOHYDRATE

FD&C RED NO. 40

SODIUM STARCH GLYCOLATE TYPE A POTATO

Active Moieties

METHOTREXATE