Cellular therapy · BLA
Casgevy (Exagamglogene autotemcel) NDC 51167-290
Exagamglogene autotemcel 13000000 1/mL · Injection, Suspension · Intravenous · Vertex Pharmaceuticals Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51167-290-09 | 51167029009 | 9 VIAL in 1 CARTON (51167-290-09) / 20 mL in 1 VIAL (51167-290-01)Marketed from Dec 8, 2023 |
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)
- Casgevy
- Generic name (nonproprietary)
- exagamglogene autotemcel
- Active ingredients
- Exagamglogene autotemcel — 13000000 1/mL
- Dosage form
- Injection, Suspension
- Route
- Intravenous
- Labeler
- Vertex Pharmaceuticals IncorporatedNDC labeler code 51167
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125787
- Marketing start
- Listing expires
- Identifiers
- Product ID 51167-290_680dd873-8717-41be-a143-2fc36acf07eaSPL ID 680dd873-8717-41be-a143-2fc36acf07eaSPL set ID 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846RxCUI 2671671, 2671677UNII S53L777GM8
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
N451167029009followed by a unit qualifier and the quantityPackage 51167-0290-09. 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)
1. INDICATIONS AND USAGE CASGEVY is indicated for the treatment of patients aged 2 years and older with: sickle cell disease (SCD) with recurrent vaso-occlusive crises transfusion-dependent β - thalassemia (TDT) CASGEVY is an autologous genome edited hematopoietic stem cell-based gene therapy indicated for the treatment of patients aged 2 years and older with: sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs). ( 1 ) transfusion-dependent β-thalassemia (TDT). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 51167-290
- What is NDC 51167-290?
- 51167-290 is the product NDC for Casgevy (exagamglogene autotemcel), Exagamglogene autotemcel 13000000 1/mL injection, suspension, listed with the FDA by Vertex Pharmaceuticals Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Casgevy (Exagamglogene autotemcel).
- What is the active ingredient?
- Exagamglogene autotemcel.
- Who is the labeler?
- Vertex Pharmaceuticals Incorporated, NDC labeler code 51167. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Casgevy?
- 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.