NDC 70437-240

Nerlynx

Neratinib

Nerlynx is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Puma Biotechnology, Inc.. The primary component is Neratinib Maleate.

• Product ID: 70437-240_70480f9b-1eb1-7bf0-e053-2991aa0a8e13
• NDC: 70437-240
• Product Type: Human Prescription Drug
• Proprietary Name: Nerlynx
• Generic Name: Neratinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-17
• Marketing Category: NDA / NDA
• Application Number: NDA208051
• Labeler Name: Puma Biotechnology, Inc.
• Substance Name: NERATINIB MALEATE
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70437-240-18

1 BOTTLE in 1 BOX (70437-240-18) > 180 TABLET in 1 BOTTLE

• Marketing Start Date: 2017-07-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70437-240-26 [70437024026]

Nerlynx TABLET

• Marketing Category: NDA
• Application Number: NDA208051
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-17
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-07

NDC 70437-240-18 [70437024018]

Nerlynx TABLET

• Marketing Category: NDA
• Application Number: NDA208051
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-17
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-07

Drug Details

Active Ingredients

Ingredient	Strength
NERATINIB MALEATE	40 mg/1

OpenFDA Data

• SPL SET ID: d1e41dcf-e82a-47c2-a0ad-6c6eef621834
• Manufacturer:
  • Puma Biotechnology, Inc.
• UNII:
  • 9RM7XY23ZS
• RxNorm Concept Unique ID - RxCUI:
  • 1940654
  • 1940648
• UPC Code:
  • 0370437240264
  • 0370437240189

Pharmacological Class

• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]