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NDC 59676-0604-14 ERLEADA 240 mg/1 Details
ERLEADA 240 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: 59676-0604-14Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Apalutamide
Product Information
| NDC | 59676-0604 |
|---|---|
| Product ID | 59676-604_0e3961a5-725a-f825-e063-6394a90ad85d |
| Associated GPIs | |
| GCN Sequence Number | 084444 |
| GCN Sequence Number Description | apalutamide TABLET 240 MG ORAL |
| HIC3 | V1J |
| HIC3 Description | ANTINEOPLASTIC - ANTIANDROGENIC AGENTS |
| GCN | 53749 |
| 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 | 240 |
| 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 59676-0604-14 (59676060414)
| NDC Package Code | 59676-604-14 |
|---|---|
| Billing NDC | 59676060414 |
| Package | 1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2023-02-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |