Prescription drug · BLA
Rylaze NDC 68727-900
asparaginase erwinia chrysanthemi (recombinant)-rywn · Asparaginase 20 mg/mL · Injection · Intramuscular · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68727-900-03 | 68727090003 | 3 VIAL, SINGLE-DOSE in 1 CARTON (68727-900-03) / .5 mL in 1 VIAL, SINGLE-DOSE (68727-900-01)Marketed from Jun 30, 2021 |
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)
- Rylaze
- Generic name (nonproprietary)
- asparaginase erwinia chrysanthemi (recombinant)-rywn
- Active ingredients
- Asparaginase — 20 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Jazz Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761179
- Marketing start
- Listing expires
- Other FDA classes
- Asparaginase (Chemical structure)
- Identifiers
- Product ID 68727-900_cca29ff5-d000-43da-b64a-c65816a8a9c4SPL ID cca29ff5-d000-43da-b64a-c65816a8a9c4SPL set ID 857e53aa-1098-4dad-b654-0276cdd43e03RxCUI 2561251, 2561256UNII G4FQ3CKY5R
- Pharmacologic class
- Asparagine-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
N468727090003followed by a unit qualifier and the quantityPackage 68727-0900-03. 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)
RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. ( 1 )
Excerpt only. Read the full label for complete information.