ELOCTATE
- Product NDC
- 71104-805
- 11-digit product format
- 711040805
- Labeler code
- 71104
- Product ID
- 71104-805_e600c559-32d8-4818-b600-141cc0d74cea
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Antihemophilic Factor (Recombinant), Fc Fusion Protein
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Bioverativ Therapeutics Inc.
- Application
- BLA125487
- Marketing category
- BLA
- Marketing start
- 2017-09-06
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ELOCTATE
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71104-487-08 | ELOCTATE | 3 mL in 1 VIAL | POWDER, FOR SOLUTION | 3 mL | 1500 [iU] in 3mL | 10 |
| 71104-805-01 | ELOCTATE | 1 in 1 KIT | KIT | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71104-805 | ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOVERATIV THERAPEUTICS INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20230526_e1419c33-ef07-4268-be1f-c8993502d597.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71104-487-08 | 71104048708 | 3 mL in 1 VIAL | 3 ml | | | | | Historical |
| 71104-805-01 | 71104080501 | 1 KIT in 1 KIT (71104-805-01) * 3 mL in 1 VIAL (71104-487-08) * 3 mL in 1 SYRINGE (71104-035-01) | 1 kit | 2017-09-06 | 0000-00-00 | No | No | Current |