Ruconest
- Product NDC
- 71274-350
- 11-digit product format
- 712740350
- Labeler code
- 71274
- Product ID
- 71274-350_a742815a-7705-9153-e053-2995a90a562d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- c1 esterase inhibitor recombinant
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pharming Healthcare Inc.
- Application
- BLA125495
- Marketing category
- BLA
- Marketing start
- 2018-04-01
- Substance
- CONESTAT ALFA
- Active strength
- 2100 U/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ruconest
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CONESTAT ALFA | 2100 U/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QS67N4551 |
| Rxcui | 1599836, 1599841 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71274-350-01 | Ruconest | 1 in 1 VIAL, SINGLE-USE | INJECTION, POWDER, FOR SOLUTION | 1 | | 3 |
| 71274-350-02 | Ruconest | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71274-350 | RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [PHARMING HEALTHCARE INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20200605_66d3fecb-32a4-7781-e053-2a91aa0a83ca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71274-350-01 | 71274035001 | 1 in 1 VIAL, SINGLE-USE | | | | | Historical |
| 71274-350-02 | 71274035002 | 1 VIAL, SINGLE-USE in 1 CARTON (71274-350-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (71274-350-01) | 2018-04-01 | 0000-00-00 | No | No | Current |