Lynparza
- Product NDC
- 0310-0569
- 11-digit product format
- 003100569
- Labeler code
- 0310
- Product ID
- 0310-0569_0142c57f-6211-4638-8c48-c215686871b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olaparib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA208558
- Marketing category
- NDA
- Marketing start
- 2017-08-17
- Substance
- OLAPARIB
- Active strength
- 100 mg/1
- Pharmacologic classes
- Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase 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 |
|---|
| WOH1JD9AR8 | OLAPARIB | 763113-22-0 | OLAPARIB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0310-0569-12 | 00310056912 | 120 TABLET, FILM COATED in 1 BOTTLE (0310-0569-12) | 2025-02-18 | No | No | Historical |
| 0310-0569-60 | 00310056960 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0569-60) | 2025-02-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lynparza | AstraZeneca Pharmaceuticals LP | AstraZeneca PLC | 2025-07-10 | HUMAN PRESCRIPTION DRUG LABEL | 38 |