ESPEROCT
- Product NDC
- 0169-8400
- 11-digit product format
- 001698400
- Labeler code
- 0169
- Product ID
- 0169-8400_d47af230-b125-4bd9-b36c-51e8f90b22bc
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- antihemophilic factor (recombinant), glycopegylated-exei
- Dosage form
- KIT
- Labeler
- Novo Nordisk
- Application
- BLA125671
- Marketing category
- BLA
- Marketing start
- 2019-02-19
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESPEROCT
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-8400-01 | ESPEROCT | 1 in 1 KIT | KIT | 1 | | 7 |
| 0169-8401-11 | ESPEROCT | 4 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 4 mL | 750 [iU] in 1mL | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-8400 | ESPEROCT (ANTIHEMOPHILIC FACTOR (RECOMBINANT), GLYCOPEGYLATED-EXEI) KIT [NOVO NORDISK] | 7 | Current NDC, 2 package rows | 20240726_562f94e8-825f-4d7f-b93c-b783ac3a43bc.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125671 | Esperoct | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0169-8400-01 | 00169840001 | 1 KIT in 1 KIT (0169-8400-01) * 4 mL in 1 VIAL, GLASS (0169-8401-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) | 1 kit | 2019-02-19 | No | No | Current |
| 0169-8401-11 | 00169840111 | 4 mL in 1 VIAL, GLASS | 4 ml | | | | Historical |