EKTERLY
- Product NDC
- 82928-300
- 11-digit product format
- 829280300
- Labeler code
- 82928
- Product ID
- 82928-300_538c012b-84e0-4c90-934f-6f4d96eb9530
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sebetralstat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KalVista Pharmaceuticals Ltd
- Application
- NDA219301
- Marketing category
- NDA
- Marketing start
- 2025-07-07
- Substance
- SEBETRALSTAT
- Active strength
- 300 mg/1
- Pharmacologic classes
- Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EKTERLY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEBETRALSTAT | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O5ZD2TU2B7 |
| Rxcui | 2717949, 2717955 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82928-300-01 | EKTERLY | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 82928-300-02 | EKTERLY | 2 in 1 BLISTER PACK | TABLET | 2 | | 4 |
| 82928-300-04 | EKTERLY | 4 in 1 CARTON | TABLET | 4 | | 4 |
| 82928-300-05 | EKTERLY | 2 in 1 CARTON | TABLET | 2 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82928-300-01 | 82928030001 | 1 in 1 BLISTER PACK | | | | | Historical |
| 82928-300-02 | 82928030002 | 2 in 1 BLISTER PACK | | | | | Historical |
| 82928-300-04 | 82928030004 | 4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01) | 4 blister pack | 2025-07-07 | No | No | Current |
| 82928-300-05 | 82928030005 | 2 in 1 CARTON | | | | | Historical |