Prescription drug · BLA
Nucala (Mepolizumab) NDC 0173-0904
Mepolizumab 40 mg/.4mL · Injection, Solution · Subcutaneous · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0173-0904-42 | 00173090442 | 1 SYRINGE in 1 CARTON (0173-0904-42) / .4 mL in 1 SYRINGEMarketed from Jan 22, 2022 |
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)
- Nucala
- Generic name (nonproprietary)
- mepolizumab
- Active ingredients
- Mepolizumab — 40 mg/.4mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- GlaxoSmithKline LLCNDC labeler code 0173
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761122
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-5 Antagonists (Mechanism)
- Identifiers
- Product ID 0173-0904_869b75ba-b2a0-406e-9ed2-136b75763d78SPL ID 869b75ba-b2a0-406e-9ed2-136b75763d78SPL set ID fefb887c-e4ac-431e-8893-e9d1a5a63feaRxCUI 1720601, 1720606, 2170990, 2170993, 2173820, 2173822, 2596444, 2596445UNII 90Z2UF0E52
- Pharmacologic class
- Interleukin-5 Antagonist
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
N400173090442followed by a unit qualifier and the quantityPackage 00173-0904-42. 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)
NUCALA is an interleukin-5 (IL-5) antagonist 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 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. ( 1.3 ) • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.4 ) • The treatment of adult and pediatric patients aged 12 ye…
Excerpt only. Read the full label for complete information.
About NDC 0173-0904
- What is NDC 0173-0904?
- 0173-0904 is the product NDC for Nucala (mepolizumab), Mepolizumab 40 mg/.4mL injection, solution, listed with the FDA by GlaxoSmithKline LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nucala (Mepolizumab).
- What is the active ingredient?
- Mepolizumab.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 0173. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nucala?
- 2 other product NDCs are listed under this name. See all Nucala NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nucala products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nucalamepolizumab | Mepolizumab 100 mg/mL | Injection, SolutionSubcutaneous | GlaxoSmithKline LLC | 0173-0892 | 00173-0892-0100173-0892-4200173-0892-61+1 more |
| Nucalamepolizumab | Mepolizumab 100 mg/mL | Injection, Powder, For solutionSubcutaneous | GlaxoSmithKline LLC | 0173-0881 | 00173-0881-0100173-0881-61 |
Other NDCs under BLA 761122
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 |
|---|---|---|---|---|
| Nucalamepolizumab | Mepolizumab 100 mg/mL | Injection, SolutionSubcutaneous | GlaxoSmithKline LLC | 0173-0892 |