ERLEADA
- Product NDC
- 59676-604
- 11-digit product format
- 596760604
- Labeler code
- 59676
- Product ID
- 59676-604_8d917bea-59a6-4338-b818-6ad5c62d02f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Apalutamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Products, LP
- Application
- NDA210951
- Marketing category
- NDA
- Marketing start
- 2018-02-14
- Substance
- APALUTAMIDE
- Active strength
- 240 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 4T36H88UA7 | APALUTAMIDE | 956104-40-8 | APALUTAMIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59676-604-14 | 59676060414 | 1 BLISTER PACK in 1 CARTON (59676-604-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-02-17 | Yes | No | Historical |
| 59676-604-30 | 59676060430 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-604-30) | | 2023-02-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ERLEADA | Janssen Products, LP | Janssen Pharmaceuticals, Inc. | Janssen Pharmaceutica NV | Janssen Cilag SpA | Johnson & Johnson Private Limited | Janssen Ortho LLC | Catalent Pharma Solutions, LLC | 2026-03-10 | HUMAN PRESCRIPTION DRUG LABEL | 28 |