Methotrexate

Product NDC
71335-2221
11-digit product format
713352221
Labeler code
71335
Product ID
71335-2221_5488dfc1-8f40-4f52-ab27-f08e77b8c5c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210454
Marketing category
ANDA
Marketing start
2020-01-30
Substance
METHOTREXATE SODIUM
Active strength
2.5 mg/1
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methotrexate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE SODIUM2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3IG1E710ZN
Rxcui105585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2221-17133522210130 TABLET in 1 BOTTLE (71335-2221-1) 30 tablet2023-08-15NoNoHistorical
71335-2221-27133522210212 TABLET in 1 BOTTLE (71335-2221-2) 12 tablet2023-08-15NoNoHistorical
71335-2221-37133522210320 TABLET in 1 BOTTLE (71335-2221-3) 20 tablet2023-08-15NoNoHistorical
71335-2221-471335222104100 TABLET in 1 BOTTLE (71335-2221-4) 100 tablet2023-08-15NoNoHistorical
71335-2221-57133522210536 TABLET in 1 BOTTLE (71335-2221-5) 36 tablet2023-08-15NoNoHistorical
71335-2221-67133522210624 TABLET in 1 BOTTLE (71335-2221-6) 24 tablet2023-08-15NoNoHistorical
71335-2221-77133522210790 TABLET in 1 BOTTLE (71335-2221-7) 90 tablet2023-08-15NoNoHistorical
71335-2221-8713352221084 TABLET in 1 BOTTLE (71335-2221-8) 4 tablet2023-08-15NoNoHistorical