Label: IMATINIB MESYLATE tablet, film coated
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NDC Code(s):
70771-1394-5,
70771-1394-9,
70771-1395-2,
70771-1395-3, view more70771-1395-5, 70771-1395-8, 70771-1395-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IMATINIB MESYLATE
imatinib mesylate tablet, film coatedProduct 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 2 NDC:70771-1394-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210658 01/21/2021 IMATINIB MESYLATE
imatinib mesylate tablet, film coatedProduct 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 2 NDC:70771-1395-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2021 3 NDC:70771-1395-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2021 4 NDC:70771-1395-8 3 in 1 CARTON 01/21/2021 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 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)
