METHOTREXATE- methotrexate tablet 
Cadila Healthcare Limited

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Methotrexate tablet, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1058-1

Methotrexate tablets, USP   2.5 mg

Rx only

36 tablets

Methotrexate tablets, USP
METHOTREXATE 
methotrexate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1) METHOTREXATE2.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code L2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1058-336 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
2NDC:70771-1058-990 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
3NDC:70771-1058-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
4NDC:70771-1058-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
5NDC:70771-1058-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2017
6NDC:70771-1058-7100 in 1 CARTON02/09/2017
6NDC:70771-1058-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20781202/09/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1058) , MANUFACTURE(70771-1058)

Revised: 7/2020
Document Id: 9be3f6a3-b6d7-4b38-af11-4844c1ec9cf1
Set id: 59ea7b32-2b6d-4197-92c3-015936f04ebe
Version: 4
Effective Time: 20200728
 
Cadila Healthcare Limited