Prescription drug · BLA
Fasenra (Benralizumab) NDC 0310-1745
Benralizumab 10 mg/.5mL · Injection, Solution · Subcutaneous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-1745-01 | 00310174501 | 1 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGEMarketed from Jun 3, 2024 | |
| 0310-1745-95 | 00310174595 | 1 CARTRIDGE in 1 CARTON (0310-1745-95) / .5 mL in 1 CARTRIDGEMarketed from Jun 3, 2024 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Fasenra
- Generic name (nonproprietary)
- benralizumab
- Active ingredients
- Benralizumab — 10 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761070
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin 5 Receptor alpha-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0310-1745_b78fbf2b-888c-41e2-bdab-cb5cd1ebb8feSPL ID b78fbf2b-888c-41e2-bdab-cb5cd1ebb8feSPL set ID da6aca1a-19ed-44a4-abb7-696c7d58b784RxCUI 1989104, 1989109, 2205632, 2205634, 2679499, 2679502UNII 71492GE1FX
- Pharmacologic class
- Interleukin-5 Receptor alpha-directed Cytolytic Antibody
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
N400310174501followed by a unit qualifier and the quantityPackage 00310-1745-01. 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)
FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 ) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.2 ) • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pe…
Excerpt only. Read the full label for complete information.
About NDC 0310-1745
- What is NDC 0310-1745?
- 0310-1745 is the product NDC for Fasenra (benralizumab), Benralizumab 10 mg/.5mL injection, solution, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fasenra (Benralizumab).
- What is the active ingredient?
- Benralizumab.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fasenra?
- 2 other product NDCs are listed under this name. See all Fasenra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fasenra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fasenrabenralizumab | Benralizumab 30 mg/mL | Injection, SolutionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-1830 | 00310-1830-3000310-1830-85 |
| Fasenrabenralizumab | Benralizumab 30 mg/mL | Injection, SolutionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-1730 | 00310-1730-3000310-1730-85 |
Other NDCs under BLA 761070
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fasenrabenralizumab | Benralizumab 30 mg/mL | Injection, SolutionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-1730 |
| Fasenrabenralizumab | Benralizumab 30 mg/mL | Injection, SolutionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-1830 |