Lynparza
- Product NDC
- 0310-0668
- 11-digit product format
- 003100668
- Labeler code
- 0310
- Product ID
- 0310-0668_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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lynparza
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLAPARIB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WOH1JD9AR8 |
| Rxcui | 1942482, 1942485, 1942487, 1942489 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-0668-12 | Lynparza | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 38 |
| 0310-0668-60 | Lynparza | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 38 |
| 0310-0668-95 | Lynparza | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 38 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-0668 | LYNPARZA (OLAPARIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 37 | Current NDC, Legacy NDC, 3 package rows | 20250223_741ff3e3-dc1a-45a6-84e5-2481b27131aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-0668-12 | 00310066812 | 120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12) | 2017-08-17 | 0000-00-00 | No | No | Current |
| 0310-0668-60 | 00310066860 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60) | 2017-08-17 | 0000-00-00 | No | No | Current |
| 0310-0668-95 | 00310066895 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-95) | 2022-09-01 | 0000-00-00 | Yes | No | Current |