ISEMBYLD
- Product NDC
- 84717-150
- 11-digit product format
- 847170150
- Labeler code
- 84717
- Product ID
- 84717-150_5554cf70-b144-11f1-ab3b-0800200c9a66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apitegromab-mstn
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Scholar Rock, Inc.
- Application
- BLA761463
- Marketing category
- BLA
- Marketing start
- 2026-09-11
- Substance
- APITEGROMAB
- Active strength
- 150 mg/3mL
- 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
- ISEMBYLD
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APITEGROMAB | 150 mg/3mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761463 | Isembyld | apitegromab-mstn | 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 |
|---|
| 84717-150-01 | 84717015001 | 1 VIAL in 1 CARTON (84717-150-01) / 3 mL in 1 VIAL | 1 vial | 2026-09-11 | No | No | Current |