AFSTYLA
- Product NDC
- 69911-480
- 11-digit product format
- 699110480
- Labeler code
- 69911
- Product ID
- 69911-480_757ccd2f-85b7-440f-905f-b999e2d1dd4b
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT
- Dosage form
- KIT
- Labeler
- CSL Behring Lengnau AG
- Application
- BLA125591
- Marketing category
- BLA
- Marketing start
- 2017-03-28
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AFSTYLA
- Brand name suffix
- Antihemophilic Factor (Recombinant), Single Chain
- 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 |
|---|
| 69911-480-02 | AFSTYLA Antihemophilic Factor (Recombinant), Single Chain | 1 in 1 CARTON | KIT | 1 | | 13 |
| 69911-490-01 | AFSTYLA Antihemophilic Factor (Recombinant), Single Chain | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, FOR SOLUTION | 5 mL | 1500 [iU] in 5mL | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69911-480 | AFSTYLA ANTIHEMOPHILIC FACTOR (RECOMBINANT), SINGLE CHAIN (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [CSL BEHRING LENGNAU AG] | 13 | Current NDC, Legacy NDC, 2 package rows | 20230630_51f19873-a63f-4229-9477-5da4ecf31cde.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 |
|---|
| 69911-480-02 | 69911048002 | 1 KIT in 1 CARTON (69911-480-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-490-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-84) | 1 kit | 2017-03-28 | 0000-00-00 | No | No | Current |
| 69911-490-01 | 69911049001 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |