Prescription drug · BLA
Revcovi (Elapegademase-lvlr) NDC 10122-502
Elapegademase 1.6 mg/mL · Injection · Intramuscular · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-502-01 | 1012205020110122050201 | 1 VIAL in 1 CARTON (10122-502-01) / 1.5 mL in 1 VIALMarketed from Oct 5, 2018 |
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)
- Revcovi
- Generic name (nonproprietary)
- elapegademase-lvlr
- Active ingredients
- Elapegademase — 1.6 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Chiesi USA, Inc.NDC labeler code 10122
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761092
- Marketing start
- Listing expires
- Identifiers
- Product ID 10122-502_1b1625bb-25b0-4845-af56-5c06a0715672SPL ID 1b1625bb-25b0-4845-af56-5c06a0715672SPL set ID 8c073f84-cdd0-40e4-b3a9-172687267f28RxCUI 2059223, 2059228UNII 9R3D3Y0UHS
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
N410122050201followed by a unit qualifier and the quantityPackage 10122-0502-01. 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)
REVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. REVCOVI is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 10122-502
- What is NDC 10122-502?
- 10122-502 is the product NDC for Revcovi (elapegademase-lvlr), Elapegademase 1.6 mg/mL injection, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Revcovi (Elapegademase-lvlr).
- What is the active ingredient?
- Elapegademase.
- Who is the labeler?
- Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Revcovi?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.