Prescription drug · NDA
Lynparza (Olaparib) NDC 0310-0569
Olaparib 100 mg/1 · Tablet, Film coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-0569-12 | 00310056912 | 120 TABLET, FILM COATED in 1 BOTTLE (0310-0569-12)Marketed from Feb 18, 2025 | |
| 0310-0569-60 | 00310056960 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0569-60)Marketed from Feb 13, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Lynparza
- Generic name (nonproprietary)
- olaparib
- Active ingredients
- Olaparib — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208558
- Marketing start
- Listing expires
- Other FDA classes
- Poly(ADP-Ribose) Polymerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-0569_0142c57f-6211-4638-8c48-c215686871b8SPL ID 0142c57f-6211-4638-8c48-c215686871b8SPL set ID 741ff3e3-dc1a-45a6-84e5-2481b27131aaRxCUI 1942482, 1942485, 1942487, 1942489UNII WOH1JD9AR8
- Pharmacologic class
- Poly(ADP-Ribose) Polymerase Inhibitor
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
N400310056912followed by a unit qualifier and the quantityPackage 00310-0569-12. 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)
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.1 , 2.1 ) • in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based c…
Excerpt only. Read the full label for complete information.
About NDC 0310-0569
- What is NDC 0310-0569?
- 0310-0569 is the product NDC for Lynparza (olaparib), Olaparib 100 mg/1 tablet, film coated, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lynparza (Olaparib).
- What is the active ingredient?
- Olaparib.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lynparza?
- 3 other product NDCs are listed under this name. See all Lynparza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lynparza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lynparzaolaparib | Olaparib 150 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0578 | 00310-0578-1200310-0578-60 |
| Lynparzaolaparib | Olaparib 100 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0668 | 00310-0668-1200310-0668-6000310-0668-95 |
| Lynparzaolaparib | Olaparib 150 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0679 | 00310-0679-1200310-0679-6000310-0679-95 |
Other NDCs under NDA 208558
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 |
|---|---|---|---|---|
| Lynparzaolaparib | Olaparib 150 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0578 |
| Lynparzaolaparib | Olaparib 100 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0668 |
| Lynparzaolaparib | Olaparib 150 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0679 |