Imatinib Mesylate Tablets

imatinib mesylate by

Drug Labeling and Warnings

imatinib mesylate by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IMATINIB MESYLATE- imatinib mesylate tablet, film coated 
Zydus Lifesciences 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

NDC: 70771-1395-9

Imatinib Mesylate Tablets, 400 mg

90 Tablets

Rx only

IMATINIB MESYLATE 
imatinib mesylate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1394
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI)	IMATINIB	100 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (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
Color	YELLOW (PALE YELLOW TO YELLOW)	Score	2 pieces
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	244
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1394-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2021	03/25/2025
2	NDC: 70771-1394-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2021	03/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210658	01/21/2021	04/18/2025

IMATINIB MESYLATE 
imatinib mesylate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1395
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IMATINIB MESYLATE (UNII: 8A1O1M485B) (IMATINIB - UNII:BKJ8M8G5HI)	IMATINIB	400 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (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
Color	YELLOW (PALE YELLOW TO YELLOW)	Score	2 pieces
Shape	OVAL (ovaloid)	Size	19mm
Flavor		Imprint Code	245
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1395-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2021	03/25/2025
2	NDC: 70771-1395-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2021	03/25/2025
3	NDC: 70771-1395-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2021	03/25/2025
4	NDC: 70771-1395-8	3 in 1 CARTON	01/21/2021	03/25/2025
4	NDC: 70771-1395-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210658	01/21/2021	04/18/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1394, 70771-1395) , MANUFACTURE(70771-1394, 70771-1395)

Revised: 4/2025

Document Id: db0f94b6-fac2-42c0-9430-0ecdcfcf6496

34391-3

Set id: f3296b6b-fa17-41fa-bdaa-90186f58684e

Version: 4

Effective Time: 20250418