Methotrexate (Page 8 of )

METHOTREXATE — methotrexate tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1058-1

Methotrexate tablets, USP 2.5 mg

Rx only

36 tablets

Methotrexate tablets, USP
(click image for full-size original)
METHOTREXATE
methotrexate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1058
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE (METHOTREXATE) METHOTREXATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color YELLOW (YELLOW) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code L2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1058-3 36 TABLET in 1 BOTTLE None
2 NDC:70771-1058-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1058-1 100 TABLET in 1 BOTTLE None
4 NDC:70771-1058-5 500 TABLET in 1 BOTTLE None
5 NDC:70771-1058-0 1000 TABLET in 1 BOTTLE None
6 NDC:70771-1058-7 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1058-2)
6 NDC:70771-1058-2 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1058-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207812 02/09/2017
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1058), MANUFACTURE (70771-1058)

Revised: 10/2022 Zydus Lifesciences Limited

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