Prescription drug · NDA
Rubraca (Rucaparib) NDC 82154-0785
Rucaparib camsylate 300 mg/1 · Tablet, Film coated · Oral · pharmaand GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82154-0785-1 | 82154078501 | 60 TABLET, FILM COATED in 1 BOTTLE (82154-0785-1)Marketed from Dec 19, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Rubraca
- Generic name (nonproprietary)
- rucaparib
- Active ingredients
- Rucaparib camsylate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- pharmaand GmbHNDC labeler code 82154
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209115
- Marketing start
- Listing expires
- Other FDA classes
- Poly(ADP-Ribose) Polymerase Inhibitors (Mechanism)
- Identifiers
- Product ID 82154-0785_473a8026-e822-2a9e-e063-6294a90a5c06SPL ID 473a8026-e822-2a9e-e063-6294a90a5c06SPL set ID 0295d202-1cfe-7659-e063-6294a90a476eRxCUI 1862584, 1862590, 1862593, 1862595, 1921587, 1921589UNII 41AX9SJ8KO
- 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
N482154078501followed by a unit qualifier and the quantityPackage 82154-0785-01. 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)
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. ( 1.1 ) Prostate cancer for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. ( 1.2 , 2.1 …
Excerpt only. Read the full label for complete information.
About NDC 82154-0785
- What is NDC 82154-0785?
- 82154-0785 is the product NDC for Rubraca (rucaparib), Rucaparib camsylate 300 mg/1 tablet, film coated, listed with the FDA by pharmaand GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rubraca (Rucaparib).
- What is the active ingredient?
- Rucaparib camsylate.
- Who is the labeler?
- pharmaand GmbH, NDC labeler code 82154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rubraca?
- 2 other product NDCs are listed under this name. See all Rubraca NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rubraca products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rubracarucaparib | Rucaparib camsylate 250 mg/1 | Tablet, Film coatedOral | pharmaand GmbH | 82154-0784 | 82154-0784-01 |
| Rubracarucaparib | Rucaparib camsylate 200 mg/1 | Tablet, Film coatedOral | pharmaand GmbH | 82154-0783 | 82154-0783-01 |
Other NDCs under NDA 209115
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 |
|---|---|---|---|---|
| Rubracarucaparib | Rucaparib camsylate 200 mg/1 | Tablet, Film coatedOral | pharmaand GmbH | 82154-0783 |
| Rubracarucaparib | Rucaparib camsylate 250 mg/1 | Tablet, Film coatedOral | pharmaand GmbH | 82154-0784 |