Imatinib Mesylate

IMATINIB MESYLATE — imatinib mesylate tablet, film coated
Zydus Lifesciences Limited

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IMATINIB MESYLATE (IMATINIB) IMATINIB 100 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE MANNITOL POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE

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 Multilevel Packaging 1 NDC:70771-1394-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1394-5 500 TABLET, FILM COATED in 1 BOTTLE None

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 coated

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IMATINIB MESYLATE (IMATINIB) IMATINIB 400 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE MANNITOL POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE

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 Multilevel Packaging 1 NDC:70771-1395-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1395-5 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1395-3 30 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:70771-1395-8 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1395-2) 4 NDC:70771-1395-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1395-8)

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	Operations
Zydus Lifesciences Limited		863362789	ANALYSIS (70771-1394), ANALYSIS (70771-1395), MANUFACTURE (70771-1394), MANUFACTURE (70771-1395)

Revised: 10/2022 Zydus Lifesciences Limited