NDC 0078-0526

Tasigna

Nilotinib

Tasigna is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Nilotinib.

• Product ID: 0078-0526_404b85a1-6329-432c-a18f-a9588c009551
• NDC: 0078-0526
• Product Type: Human Prescription Drug
• Proprietary Name: Tasigna
• Generic Name: Nilotinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2007-10-29
• Marketing Category: NDA / NDA
• Application Number: NDA022068
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: NILOTINIB
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0526-51

28 CAPSULE in 1 BLISTER PACK (0078-0526-51)

• Marketing Start Date: 2007-10-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0526-51 [00078052651]

Tasigna CAPSULE

• Marketing Category: NDA
• Application Number: NDA022068
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-10-29

NDC 0078-0526-87 [00078052687]

Tasigna CAPSULE

• Marketing Category: NDA
• Application Number: NDA022068
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-10-29

Drug Details

Active Ingredients

Ingredient	Strength
NILOTINIB	200 mg/1

OpenFDA Data

• SPL SET ID: 6093952a-5248-45cb-ad17-33716a411146
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • F41401512X
• RxNorm Concept Unique ID - RxCUI:
  • 2002717
  • 746606
  • 997653
  • 2002719
  • 746609
  • 1002300
• UPC Code:
  • 0300780951661

Pharmacological Class

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

NDC Crossover Matching brand name "Tasigna" or generic name "Nilotinib"

NDC	Brand Name	Generic Name
0078-0526	Tasigna	nilotinib
0078-0592	Tasigna	nilotinib
0078-0951	Tasigna	nilotinib