Prescription drug · NDA
Erleada (Apalutamide) NDC 59676-604
Apalutamide 240 mg/1 · Tablet, Film coated · Oral · Janssen Products, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59676-604-14 | 59676060414 | 1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 17, 2023 · Sample package | |
| 59676-604-30 | 59676060430 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-604-30)Marketed from Feb 17, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Erleada
- Generic name (nonproprietary)
- apalutamide
- Active ingredients
- Apalutamide — 240 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Products, LPNDC labeler code 59676
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210951
- Marketing start
- Listing expires
- Identifiers
- Product ID 59676-604_8934d69e-be91-4552-8fba-ccc07e4f0a20SPL ID 8934d69e-be91-4552-8fba-ccc07e4f0a20SPL set ID d1cda4f7-cb33-46ea-b9ac-431f6452b1a5RxCUI 1999581, 1999587, 2630215, 2630217UNII 4T36H88UA7
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459676060414followed by a unit qualifier and the quantityPackage 59676-0604-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 59676-604
- What is NDC 59676-604?
- 59676-604 is the product NDC for Erleada (apalutamide), Apalutamide 240 mg/1 tablet, film coated, listed with the FDA by Janssen Products, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erleada (Apalutamide).
- What is the active ingredient?
- Apalutamide.
- Who is the labeler?
- Janssen Products, LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Erleada?
- 1 other product NDC are listed under this name. See all Erleada NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erleada products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Erleadaapalutamide | Apalutamide 60 mg/1 | Tablet, Film coatedOral | Janssen Products, LP | 59676-600 | 59676-0600-1259676-0600-56 |
Other NDCs under NDA 210951
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Erleadaapalutamide | Apalutamide 60 mg/1 | Tablet, Film coatedOral | Janssen Products, LP | 59676-600 |