NDC codes

FDA NDC Directory
Product NDC (as listed)82154-0783Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82154-0783Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
82154-0783-18215407830160 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1)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 — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 82154-0783_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

N482154078301 followed by a unit qualifier and the quantity

Package 82154-0783-01. 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.

Full label on DailyMed (opens in a new tab)

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