IDELVION
- Product NDC
- 69911-869
- 11-digit product format
- 699110869
- Labeler code
- 69911
- Product ID
- 69911-869_fc29c907-a767-4a0e-b077-8c197e7ce8b3
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Coagulation Factor IX Recombinant Human
- Dosage form
- KIT
- Labeler
- CSL Behring Lengnau AG
- Application
- BLA125582
- Marketing category
- BLA
- Marketing start
- 2018-05-30
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IDELVION
- Listing expiration
- 2026-12-31
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69911-869-02 | IDELVION | 1 in 1 CARTON | KIT | 1 | | 12 |
| 69911-879-01 | IDELVION | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 3500 [iU] in 5mL | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69911-869 | IDELVION (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [CSL BEHRING LENGNAU AG] | 12 | Current NDC, Legacy NDC, 2 package rows | 20230706_f74301bf-95e2-44ab-a8b6-98aa07b04683.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 |
|---|
| 69911-869-02 | 69911086902 | 1 KIT in 1 CARTON (69911-869-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-879-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-85) | 1 kit | 2018-05-30 | 0000-00-00 | No | No | Current |
| 69911-879-01 | 69911087901 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |