EDURANT PED
- Product NDC
- 59676-280
- 11-digit product format
- 596760280
- Labeler code
- 59676
- Product ID
- 59676-280_3d6d0fcc-0b62-b76b-e063-6294a90aea43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rilpivirine hydrochloride
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Janssen Products, LP
- Application
- NDA219016
- Marketing category
- NDA
- Marketing start
- 2024-03-15
- Substance
- RILPIVIRINE HYDROCHLORIDE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 212WAX8KDD | RILPIVIRINE HYDROCHLORIDE | 700361-47-3 | RILPIVIRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59676-280-90 | 59676028090 | 9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01) | 9 blister pack | 2024-03-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| EDURANT | Janssen Products, LP | AndersonBrecon Inc | Janssen Pharmaceutica NV | Janssen-Cilag SpA | Johnson & Johnson Private Limited | Janssen Pharmaceutical Sciences Unlimited Company | 2025-08-28 | HUMAN PRESCRIPTION DRUG LABEL | 28 |