HAEGARDA
- Product NDC
- 63833-828
- 11-digit product format
- 638330828
- Labeler code
- 63833
- Product ID
- 63833-828_c53fd34d-f366-4ee5-bbea-88201bf6b7c8
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN C1-ESTERASE INHIBITOR
- Dosage form
- KIT
- Labeler
- CSL Behring GmbH
- Application
- BLA125606
- Marketing category
- BLA
- Marketing start
- 2017-06-22
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HAEGARDA
- Brand name suffix
- C1 Esterase Inhibitor Subcutaneous (Human)
- 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 |
|---|
| 63833-828-02 | HAEGARDAC1 Esterase Inhibitor Subcutaneous (Human) | 1 in 1 CARTON | KIT | 1 | | 8 |
| 63833-838-01 | HAEGARDAC1 Esterase Inhibitor Subcutaneous (Human) | 4 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, FOR SOLUTION | 4 mL | 2000 [iU] in 4mL | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63833-828 | HAEGARDA C1 ESTERASE INHIBITOR SUBCUTANEOUS (HUMAN) (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH] | 8 | Current NDC, Legacy NDC, 2 package rows | 20220831_e270ad38-adc4-4ed5-88e3-943b93d20a57.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 |
|---|
| 63833-828-02 | 63833082802 | 1 KIT in 1 CARTON (63833-828-02) * 4 mL in 1 VIAL, SINGLE-USE (63833-838-01) * 4 mL in 1 VIAL, SINGLE-USE (63833-765-18) | 1 kit | 2017-06-22 | 0000-00-00 | No | No | Current |
| 63833-838-01 | 63833083801 | 4 mL in 1 VIAL, SINGLE-USE | 4 ml | | | | | Historical |