IMATINIB MESYLATE- imatinib mesylate tablet, film coated 
Cadila Healthcare Limited

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Imatinib Mesylate Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1394-9

Imatinib Mesylate Tablets, 100 mg

90 Tablets

Rx only

100 mg

NDC 70771-1395-9

Imatinib Mesylate Tablets, 400 mg

90 Tablets

Rx only

400 mg
IMATINIB MESYLATE 
imatinib mesylate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1394
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI) IMATINIB100 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (PALE YELLOW TO YELLOW) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 244
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1394-990 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
2NDC:70771-1394-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21065801/21/2021
IMATINIB MESYLATE 
imatinib mesylate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1395
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI) IMATINIB400 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (PALE YELLOW TO YELLOW) Score2 pieces
ShapeOVAL (ovaloid) Size19mm
FlavorImprint Code 245
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1395-990 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
2NDC:70771-1395-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
3NDC:70771-1395-330 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2021
4NDC:70771-1395-83 in 1 CARTON01/21/2021
4NDC:70771-1395-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21065801/21/2021
Labeler - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1394, 70771-1395) , MANUFACTURE(70771-1394, 70771-1395)

Revised: 10/2020
Document Id: c7e4cea9-6fa0-43ab-97d8-fea4115ed0f9
Set id: f3296b6b-fa17-41fa-bdaa-90186f58684e
Version: 1
Effective Time: 20201003
 
Cadila Healthcare Limited