NDC 0078-0671

TYKERB

Lapatinib

TYKERB is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Lapatinib Ditosylate.

• Product ID: 0078-0671_02c8a7ae-1e09-4668-bbac-090960e734c9
• NDC: 0078-0671
• Product Type: Human Prescription Drug
• Proprietary Name: TYKERB
• Generic Name: Lapatinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-03
• Marketing Category: NDA / NDA
• Application Number: NDA022059
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: LAPATINIB DITOSYLATE
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0671-19

150 TABLET in 1 BOTTLE (0078-0671-19)

• Marketing Start Date: 2016-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0671-19 [00078067119]

TYKERB TABLET

• Marketing Category: NDA
• Application Number: NDA022059
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-03

Drug Details

Active Ingredients

Ingredient	Strength
LAPATINIB DITOSYLATE	250 mg/1

OpenFDA Data

• SPL SET ID: eee37f88-ec6a-4c30-b8aa-e2c71f93088c
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • G873GX646R
• RxNorm Concept Unique ID - RxCUI:
  • 672152
  • 672149

Pharmacological Class

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

NDC Crossover Matching brand name "TYKERB" or generic name "Lapatinib"

NDC	Brand Name	Generic Name
0078-0671	TYKERB	lapatinib
68180-801	Lapatinib	lapatinib