Cellular therapy · BLA
Lyfgenia (Lovotibeglogene autotemcel) NDC 73554-1111
Lovotibeglogene autotemcel 20000000 1/20mL · Suspension · Intravenous · Genetix Biotherapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73554-1111-1 | 73554111101 | 1 mL in 1 BAG (73554-1111-1)Marketed from Dec 8, 2023 |
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)
- Lyfgenia
- Generic name (nonproprietary)
- lovotibeglogene autotemcel
- Active ingredients
- Lovotibeglogene autotemcel — 20000000 1/20mL
- Dosage form
- Suspension
- Route
- Intravenous
- Labeler
- Genetix Biotherapeutics Inc.NDC labeler code 73554
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125788
- Marketing start
- Listing expires
- Identifiers
- Product ID 73554-1111_7e6dc606-b12b-4804-a746-ae47b5e18c43SPL ID 7e6dc606-b12b-4804-a746-ae47b5e18c43SPL set ID 0d1b475e-5781-2bd1-e063-6294a90a7311RxCUI 2672691, 2672697UNII 2C6A9NH2Z8UPC 0373554111110
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
N473554111101followed by a unit qualifier and the quantityPackage 73554-1111-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
LYFGENIA is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. LYFGENIA is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. ( 1 ) Limitations of Use Following treatment with LYFGENIA, patients with α-thalassemia trait (-α3.7/-α3.7) may experience anemia with erythroid dysplasia that may require chronic red blood cell transfusions. LYFGENIA has not been studied in patients with more than two α-globin gene deletions. ( 1 ) Limitations of Use Following treatment with LYFGENIA, pati…
Excerpt only. Read the full label for complete information.
About NDC 73554-1111
- What is NDC 73554-1111?
- 73554-1111 is the product NDC for Lyfgenia (lovotibeglogene autotemcel), Lovotibeglogene autotemcel 20000000 1/20mL 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?
- Lyfgenia (Lovotibeglogene autotemcel).
- What is the active ingredient?
- Lovotibeglogene 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 Lyfgenia?
- 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.