Prescription drug · BLA
Tezspire (Tezepelumab-ekko) NDC 55513-112
Tezepelumab 210 mg/1.9mL · Injection, Solution · Subcutaneous · Amgen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-112-01 | 5551301120155513011201 | 1 SYRINGE in 1 CARTON (55513-112-01) / 1.91 mL in 1 SYRINGEMarketed from Dec 17, 2021 | |
| 55513-112-96 | 5551301129655513011296 | 1 SYRINGE in 1 CARTON (55513-112-96) / 1.91 mL in 1 SYRINGEMarketed from Dec 17, 2021 · Sample package |
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)
- Tezspire
- Generic name (nonproprietary)
- tezepelumab-ekko
- Active ingredients
- Tezepelumab — 210 mg/1.9mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Amgen IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761224
- Marketing start
- Listing expires
- Other FDA classes
- Thymic Stromal Lymphopoietin Blockers (Mechanism)
- Identifiers
- Product ID 55513-112_4eca89a7-2254-4ee1-9662-c7a84ef7c4b9SPL ID 4eca89a7-2254-4ee1-9662-c7a84ef7c4b9SPL set ID 60f0aa03-ad25-4d48-80ce-7fcfa76f325fRxCUI 2587794, 2587800, 2587803, 2587806, 2628920, 2628923UNII RJ1IW3B4QX
- Pharmacologic class
- Thymic Stromal Lymphopoietin Blocker
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
N455513011201followed by a unit qualifier and the quantityPackage 55513-0112-01. 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)
TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1.1 ) • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) 1.1 Asthma TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: TEZSPIRE is not indicated for the r…
Excerpt only. Read the full label for complete information.
About NDC 55513-112
- What is NDC 55513-112?
- 55513-112 is the product NDC for Tezspire (tezepelumab-ekko), Tezepelumab 210 mg/1.9mL injection, solution, listed with the FDA by Amgen Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tezspire (Tezepelumab-ekko).
- What is the active ingredient?
- Tezepelumab.
- Who is the labeler?
- Amgen Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tezspire?
- 1 other product NDC are listed under this name. See all Tezspire NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tezspire products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under BLA 761224
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.