Methotrexate (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

2.5 mg 36ct Label
(click image for full-size original)
METHOTREXATE
methotrexate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1423
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE SODIUM (METHOTREXATE) METHOTREXATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code A;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1423-6 36 TABLET in 1 BOTTLE None
2 NDC:69238-1423-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210040 12/29/2017
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 analysis (69238-1423), label (69238-1423), manufacture (69238-1423), pack (69238-1423)

Revised: 07/2022 Amneal Pharmaceuticals NY LLC

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