ONSWIK
- Product NDC
- 0002-5137
- 11-digit product format
- 000025137
- Labeler code
- 0002
- Product ID
- 0002-5137_da30dc98-a2dc-4a7c-91e1-180ca496daa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin efsitora alfa-gobe
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Eli Lilly and Company
- Application
- BLA761408
- Marketing category
- BLA
- Marketing start
- 2026-09-23
- Substance
- INSULIN EFSITORA ALFA
- Active strength
- 500 [iU]/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONSWIK
- Brand name suffix
- KwikPen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN EFSITORA ALFA | 500 [iU]/mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761408 | Onswik | insulin efsitora alfa-gobe | 351(a) | Rx | 2026-09-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0002-5137-11 | 00002513711 | 1 SYRINGE in 1 CARTON (0002-5137-11) / 3 mL in 1 SYRINGE (0002-5137-01) | 1 syringe | 2026-09-23 | No | No | Current |