NDC 66828-0030

Gleevec

Imatinib Mesylate

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

• Product ID: 66828-0030_d56c24fb-196d-4775-b67f-13c5e41bd150
• NDC: 66828-0030
• 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 Pharma Produktions GmbH
• Substance Name: IMATINIB MESYLATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 66828-0030-1

100000 TABLET in 1 DRUM (66828-0030-1)

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

NDC SPL Data Element Entries

NDC 66828-0030-1 [66828003001]

Gleevec TABLET

• Marketing Category: NDA
• Application Number: NDA021588
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-05-15
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
IMATINIB MESYLATE	100 mg/1

OpenFDA Data

• SPL SET ID: d722cbed-9910-4627-b0a5-322a3e0c66ae
• Manufacturer:
  • Novartis Pharma Produktions GmbH
• UNII:
  • 8A1O1M485B

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