Prescription drug · NDA
Zejula (Niraparib) NDC 0173-0909
Niraparib tosylate 100 mg/1 · Tablet, Film coated · Oral · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0909-13 | 00173090913 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13)Marketed from Jun 27, 2023 |
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)
- Zejula
- Generic name (nonproprietary)
- niraparib
- Active ingredients
- Niraparib tosylate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214876
- Marketing start
- Listing expires
- Other FDA classes
- Poly(ADP-Ribose) Polymerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0173-0909_b5e85656-77f8-405d-982e-c3d890a0f99bSPL ID b5e85656-77f8-405d-982e-c3d890a0f99bSPL set ID b7f675e2-159c-490c-b6f4-3f16d9492b7dRxCUI 2637449, 2637452, 2637465, 2640210, 2640212, 2640214UNII 195Q483UZDUPC 0301730909138, 0301730915139
- 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
N400173090913followed by a unit qualifier and the quantityPackage 00173-0909-13. 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)
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated re…
Excerpt only. Read the full label for complete information.
About NDC 0173-0909
- What is NDC 0173-0909?
- 0173-0909 is the product NDC for Zejula (niraparib), Niraparib tosylate 100 mg/1 tablet, film coated, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zejula (Niraparib).
- What is the active ingredient?
- Niraparib tosylate.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zejula?
- 2 other product NDCs are listed under this name. See all Zejula NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zejula products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zejulaniraparib | Niraparib tosylate 200 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0912 | 00173-0912-1300173-0912-61 |
| Zejulaniraparib | Niraparib tosylate 300 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0915 | 00173-0915-1300173-0915-61 |
Other NDCs under NDA 214876
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 |
|---|---|---|---|---|
| Zejulaniraparib | Niraparib tosylate 200 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0912 |
| Zejulaniraparib | Niraparib tosylate 300 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0915 |