Prescription drug · BLA
Loargys (Pegzilarginase-nbln) NDC 81583-105
Pegzilarginase 5 mg/mL · Injection · Intravenous, Subcutaneous · Immedica Pharma US Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Loargys
- Generic name (nonproprietary)
- pegzilarginase-nbln
- Active ingredients
- Pegzilarginase — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous, Subcutaneous
- Labeler
- Immedica Pharma US Inc.NDC labeler code 81583
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761211
- Marketing start
- Listing expires
- Identifiers
- Product ID 81583-105_d5ceabf2-43a0-4746-9371-d98a39cf6cfcSPL ID d5ceabf2-43a0-4746-9371-d98a39cf6cfcSPL set ID d5ceabf2-43a0-4746-9371-d98a39cf6cfcRxCUI 2738655, 2738662, 2738664, 2738665UNII 4YV4KW88GD
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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. LOARGYS is an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. ( 1 ) T…
Excerpt only. Read the full label for complete information.
About NDC 81583-105
- What is NDC 81583-105?
- 81583-105 is the product NDC for Loargys (pegzilarginase-nbln), Pegzilarginase 5 mg/mL injection, listed with the FDA by Immedica Pharma US Inc..
- What drug is associated with this NDC?
- Loargys (Pegzilarginase-nbln).
- What is the active ingredient?
- Pegzilarginase.
- Who is the labeler?
- Immedica Pharma US Inc., NDC labeler code 81583. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loargys?
- 1 other product NDC are listed under this name. See all Loargys NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loargys products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loargyspegzilarginase-nbln | Pegzilarginase 2 mg/.4mL | InjectionIntravenous, Subcutaneous | Immedica Pharma US Inc. | 81583-102 | 81583-0102-01 |
Other NDCs under BLA 761211
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 |
|---|---|---|---|---|
| Loargyspegzilarginase-nbln | Pegzilarginase 2 mg/.4mL | InjectionIntravenous, Subcutaneous | Immedica Pharma US Inc. | 81583-102 |