NDC 50242-130

ALECENSA

Alectinib Hydrochloride

ALECENSA is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Alectinib Hydrochloride.

• Product ID: 50242-130_1129b203-b172-4c3d-81bf-11f6537567b6
• NDC: 50242-130
• Product Type: Human Prescription Drug
• Proprietary Name: ALECENSA
• Generic Name: Alectinib Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-12-11
• Marketing Category: NDA / NDA
• Application Number: NDA208434
• Labeler Name: Genentech, Inc.
• Substance Name: ALECTINIB HYDROCHLORIDE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50242-130-01

1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) > 240 CAPSULE in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2015-12-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-130-01 [50242013001]

ALECENSA CAPSULE

• Marketing Category: NDA
• Application Number: NDA208434
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-12-11

NDC 50242-130-86 [50242013086]

ALECENSA CAPSULE

• Marketing Category: NDA
• Application Number: NDA208434
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-10

Drug Details

Active Ingredients

Ingredient	Strength
ALECTINIB HYDROCHLORIDE	150 mg/1

OpenFDA Data

• SPL SET ID: 42c49deb-713b-427a-9670-08af08adcffb
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • P9YY73LO6J
• RxNorm Concept Unique ID - RxCUI:
  • 1727485
  • 1727479

Pharmacological Class

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