Prescription drug · BLA
Benlysta (Belimumab) NDC 49401-101
Belimumab 120 mg/1.5mL · Injection, Powder, Lyophilized, For solution · Intravenous · GlaxoSmithKline LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49401-101-01 | 49401010101 | 1 VIAL in 1 CARTON (49401-101-01) / 1.5 mL in 1 VIALMarketed from Mar 10, 2011 |
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)
- Benlysta
- Generic name (nonproprietary)
- belimumab
- Active ingredients
- Belimumab — 120 mg/1.5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- GlaxoSmithKline LLCNDC labeler code 49401
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125370
- Marketing start
- Listing expires
- Other FDA classes
- B Lymphocyte Stimulator-directed Antibody Interactions (Mechanism)Decreased B Lymphocyte Activation (Physiologic effect)
- Identifiers
- Product ID 49401-101_eb71b011-8919-478c-bed7-b94709fcd596SPL ID eb71b011-8919-478c-bed7-b94709fcd596SPL set ID 2fa3c528-1777-4628-8a55-a69dae2381a3RxCUI 1656395, 1656398, 1656400, 1656402, 1939296, 1939299, 1939346, 1939348UNII 73B0K5S26A
- Pharmacologic class
- B Lymphocyte Stimulator-specific Inhibitor
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
N449401010101followed by a unit qualifier and the quantityPackage 49401-0101-01. 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)
BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation. BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy; ( 1 ) • Active lupus nephritis who are receiving standard therapy. ( …
Excerpt only. Read the full label for complete information.
About NDC 49401-101
- What is NDC 49401-101?
- 49401-101 is the product NDC for Benlysta (belimumab), Belimumab 120 mg/1.5mL injection, powder, lyophilized, for 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?
- Benlysta (Belimumab).
- What is the active ingredient?
- Belimumab.
- Who is the labeler?
- GlaxoSmithKline LLC, NDC labeler code 49401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benlysta?
- 2 other product NDCs are listed under this name. See all Benlysta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benlysta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benlystabelimumab | Belimumab 200 mg/mL | SolutionSubcutaneous | GlaxoSmithKline LLC | 49401-088 | 49401-0088-0249401-0088-3549401-0088-47+2 more |
| Benlystabelimumab | Belimumab 400 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | GlaxoSmithKline LLC | 49401-102 | 49401-0102-01 |
Other NDCs under BLA 125370
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 |
|---|---|---|---|---|
| Benlystabelimumab | Belimumab 400 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | GlaxoSmithKline LLC | 49401-102 |