Prescription drug · BLA
Kalbitor (ecallantide) NDC 47783-101
Ecallantide 10 mg/mL · Injection, Solution · Subcutaneous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47783-101-01 | 47783010101 | 3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASSMarketed from Feb 2, 2010 |
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)
- Kalbitor
- Generic name (nonproprietary)
- ecallantide
- Active ingredients
- Ecallantide — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125277
- Marketing start
- Listing expires
- Other FDA classes
- Kallikrein Inhibitors (Mechanism)
- Identifiers
- Product ID 47783-101_1992039f-246f-4057-899b-987d45df152fSPL ID 1992039f-246f-4057-899b-987d45df152fSPL set ID f56aec67-c662-477c-b866-bfc23e8809cfRxCUI 884698, 884702UNII 5Q6TZN2HNM
- Pharmacologic class
- Plasma Kallikrein 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
N447783010101followed by a unit qualifier and the quantityPackage 47783-0101-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.