Prescription drug · BLA
Krystexxa (Pegloticase) NDC 75987-080
Pegloticase 8 mg/mL · Injection, Solution · Intravenous · Horizon Therapeutics USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75987-080-10 | 75987008010 | 1 VIAL in 1 CARTON (75987-080-10) / 1 mL in 1 VIALMarketed from Sep 14, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Krystexxa
- Generic name (nonproprietary)
- pegloticase
- Active ingredients
- Pegloticase — 8 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Horizon Therapeutics USA, Inc.NDC labeler code 75987
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125293
- Marketing start
- Listing expires
- Other FDA classes
- Urate Oxidase (Chemical structure)
- Identifiers
- Product ID 75987-080_57c98104-8dbe-4e55-9cb6-7b101706b053SPL ID 57c98104-8dbe-4e55-9cb6-7b101706b053SPL set ID 6e566303-d93a-4130-b764-25749829aa95RxCUI 1011653, 1011657, 2723378, 2723381UNII R581OT55EAUPC 0375987080100
- Pharmacologic class
- Uric Acid-specific Enzyme
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N475987008010followed by a unit qualifier and the quantityPackage 75987-0080-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
KRYSTEXXA ® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA ® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. ( 1 ) Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Limitations of U…
Excerpt only. Read the full label for complete information.
About NDC 75987-080
- What is NDC 75987-080?
- 75987-080 is the product NDC for Krystexxa (pegloticase), Pegloticase 8 mg/mL injection, solution, listed with the FDA by Horizon Therapeutics USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Krystexxa (Pegloticase).
- What is the active ingredient?
- Pegloticase.
- Who is the labeler?
- Horizon Therapeutics USA, Inc., NDC labeler code 75987. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Krystexxa?
- 1 other product NDC are listed under this name. See all Krystexxa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Krystexxa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Krystexxapegloticase | Pegloticase 8 mg/50mL | Injection, SolutionIntravenous | Horizon Therapeutics USA, Inc. | 75987-058 | 75987-0058-01 |
Other NDCs under BLA 125293
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 |
|---|---|---|---|---|
| Krystexxapegloticase | Pegloticase 8 mg/50mL | Injection, SolutionIntravenous | Horizon Therapeutics USA, Inc. | 75987-058 |