Cellular therapy · BLA
Zynteglo (Betibeglogene autotemcel) NDC 73554-3111
Betibeglogene autotemcel 20000000 1/1 · Suspension · Intravenous · Genetix Biotherapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73554-3111-1 | 73554311101 | 1 SUSPENSION in 1 BAG (73554-3111-1)Marketed from Aug 17, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Zynteglo
- Generic name (nonproprietary)
- betibeglogene autotemcel
- Active ingredients
- Betibeglogene autotemcel — 20000000 1/1
- Dosage form
- Suspension
- Route
- Intravenous
- Labeler
- Genetix Biotherapeutics Inc.NDC labeler code 73554
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125717
- Marketing start
- Listing expires
- Identifiers
- Product ID 73554-3111_ad3b5513-b7ff-492d-ad78-ea5a4bd44510SPL ID ad3b5513-b7ff-492d-ad78-ea5a4bd44510SPL set ID 86931613-c262-47f5-8202-bc31fa69ad3dRxCUI 2610435, 2610436UNII MEE8487RTPUPC 0373554311114
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
N473554311101followed by a unit qualifier and the quantityPackage 73554-3111-01. 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)
ZYNTEGLO is indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. ZYNTEGLO is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 73554-3111
- What is NDC 73554-3111?
- 73554-3111 is the product NDC for Zynteglo (betibeglogene autotemcel), Betibeglogene autotemcel 20000000 1/1 suspension, listed with the FDA by Genetix Biotherapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zynteglo (Betibeglogene autotemcel).
- What is the active ingredient?
- Betibeglogene autotemcel.
- Who is the labeler?
- Genetix Biotherapeutics Inc., NDC labeler code 73554. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zynteglo?
- 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.