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NDC 59676-0600-56 ERLEADA 60 mg/1 Details

ERLEADA 60 mg/1

ERLEADA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Products, LP. The primary component is APALUTAMIDE.

MedlinePlus Drug Summary

Apalutamide is used to treat certain types of prostate cancer (cancer in men that begins in the prostate [a male reproductive gland]) and has spread to other parts of the body or that has not spread to other parts of the body but has not been helped by other medical treatments. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

Related Packages: 59676-0600-56
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Apalutamide

Product Information

NDC	59676-0600
Product ID	59676-600_0e3961a5-725a-f825-e063-6394a90ad85d
Associated GPIs	21402410000320
GCN Sequence Number	078163
GCN Sequence Number Description	apalutamide TABLET 60 MG ORAL
HIC3	V1J
HIC3 Description	ANTINEOPLASTIC - ANTIANDROGENIC AGENTS
GCN	44446
HICL Sequence Number	044773
HICL Sequence Number Description	APALUTAMIDE
Brand/Generic	Brand
Proprietary Name	ERLEADA
Proprietary Name Suffix	n/a
Non-Proprietary Name	Apalutamide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	60
Active Ingredient Units	mg/1
Substance Name	APALUTAMIDE
Labeler Name	Janssen Products, LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA210951
Listing Certified Through	2025-12-31

Package

NDC 59676-0600-56 (59676060056)

Pricing Information	N/A
NDC Package Code	59676-600-56
Billing NDC	59676060056
Package	2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2019-04-01
NDC Exclude Flag	N