GENGLYCOS
- Product NDC
- 69794-334
- 11-digit product format
- 697940334
- Labeler code
- 69794
- Product ID
- 69794-334_84175036-1036-40bf-8134-df5deffa21ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pariglasgene brecaparvovec-opnr
- Dosage form
- KIT
- Labeler
- Ultragenyx Pharmaceutical Inc.
- Application
- BLA125858
- Marketing category
- BLA
- Marketing start
- 2026-09-17
- 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
- GENGLYCOS
- Listing expiration
- 2027-12-31
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125858 | GENGLYCOS | pariglasgene brecaparvovec-opnr | 351(a) | Rx | 2026-08-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69794-334-03 | 69794033403 | 1 KIT in 1 CARTON (69794-334-03) * 2 mL in 1 VIAL (69794-332-01) | 1 kit | 2026-09-17 | No | No | Current |