Berinert
- Product NDC
- 63833-825
- 11-digit product format
- 638330825
- Labeler code
- 63833
- Product ID
- 63833-825_6f3826cd-77fd-4ae0-909c-66a91dbe5f72
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN C1-ESTERASE INHIBITOR
- Dosage form
- KIT
- Labeler
- CSL Behring GmbH
- Application
- BLA125287
- Marketing category
- BLA
- Marketing start
- 2011-12-22
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Berinert
- 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 |
|---|
| 63833-825-02 | Berinert | 1 in 1 CARTON | KIT | 1 | | 33 |
| 63833-835-01 | Berinert | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 500 [iU] in 10mL | 33 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63833-825 | BERINERT (HUMAN C1-ESTERASE INHIBITOR) KIT [CSL BEHRING GMBH] | 33 | Current NDC, Legacy NDC, 2 package rows | 20210928_8ea0c7fe-da9d-4218-a080-0509e09bedc6.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 |
|---|
| 63833-825-02 | 63833082502 | 1 KIT in 1 CARTON (63833-825-02) * 10 mL in 1 VIAL (63833-835-01) * 10 mL in 1 VIAL (63833-765-15) | 1 kit | 2011-12-22 | 0000-00-00 | No | No | Current |
| 63833-835-01 | 63833083501 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |