Prescription drug · NDA
Ekterly (Sebetralstat) NDC 82928-300
Sebetralstat 300 mg/1 · Tablet · Oral · KalVista Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82928-300-04 | 82928030004 | 4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01)Marketed from Jul 3, 2025 | |
| 82928-300-05 | 82928030005 | 2 BLISTER PACK in 1 CARTON (82928-300-05) / 2 TABLET in 1 BLISTER PACK (82928-300-02)Marketed from Jul 1, 2026 |
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)
- Ekterly
- Generic name (nonproprietary)
- sebetralstat
- Active ingredients
- Sebetralstat — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KalVista Pharmaceuticals LtdNDC labeler code 82928
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219301
- Marketing start
- Listing expires
- Other FDA classes
- Kallikrein Inhibitors (Mechanism)
- Identifiers
- Product ID 82928-300_16d31d7e-dc21-4cdb-92b8-56919827a192SPL ID 16d31d7e-dc21-4cdb-92b8-56919827a192SPL set ID 1d145e2f-8e7e-2e90-e063-6294a90a4449RxCUI 2717949, 2717955UNII O5ZD2TU2B7UPC 0382928300012, 0382928300043, 0382928300029, 0382928300050
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482928030004followed by a unit qualifier and the quantityPackage 82928-0300-04. 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)
EKTERLY® is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY ® is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 82928-300
- What is NDC 82928-300?
- 82928-300 is the product NDC for Ekterly (sebetralstat), Sebetralstat 300 mg/1 tablet, listed with the FDA by KalVista Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ekterly (Sebetralstat).
- What is the active ingredient?
- Sebetralstat.
- Who is the labeler?
- KalVista Pharmaceuticals Ltd, NDC labeler code 82928. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ekterly?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.