NDC 0078-0401

Gleevec

Imatinib Mesylate

Gleevec is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Imatinib Mesylate.

• Product ID: 0078-0401_1077cda3-a7c8-482d-b8c6-a87007bbfbac
• NDC: 0078-0401
• Product Type: Human Prescription Drug
• Proprietary Name: Gleevec
• Generic Name: Imatinib Mesylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2001-05-15
• Marketing Category: NDA / NDA
• Application Number: NDA021588
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: IMATINIB MESYLATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0401-34

90 TABLET in 1 BOTTLE (0078-0401-34)

• Marketing Start Date: 2001-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0401-34 [00078040134]

Gleevec TABLET

• Marketing Category: NDA
• Application Number: NDA021588
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-05-15

Drug Details

Active Ingredients

Ingredient	Strength
IMATINIB MESYLATE	100 mg/1

OpenFDA Data

• SPL SET ID: 211ef2da-2868-4a77-8055-1cb2cd78e24b
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 8A1O1M485B
• RxNorm Concept Unique ID - RxCUI:
  • 404589
  • 404588
  • 403878
  • 403879
• UPC Code:
  • 0300780401340

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "Gleevec" or generic name "Imatinib Mesylate"

NDC	Brand Name	Generic Name
0078-0401	Gleevec	imatinib mesylate
0078-0649	Gleevec	imatinib mesylate
66828-0030	Gleevec	Gleevec
0054-0248	Imatinib Mesylate	Imatinib Mesylate
0054-0249	Imatinib Mesylate	Imatinib Mesylate
0093-7629	Imatinib Mesylate	Imatinib Mesylate
0093-7630	Imatinib Mesylate	Imatinib Mesylate
0904-6621	Imatinib Mesylate	Imatinib Mesylate
0904-6901	Imatinib Mesylate	Imatinib Mesylate
16714-704	imatinib mesylate	imatinib mesylate