Cinryze
- Product NDC
- 42227-083
- 11-digit product format
- 422270083
- Labeler code
- 42227
- Product ID
- 42227-083_421ea216-278f-4ca8-ae5d-5dafe85658a0
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN C1-ESTERASE INHIBITOR
- Dosage form
- KIT
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA125267
- Marketing category
- BLA
- Marketing start
- 2021-01-15
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cinryze
- 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 |
|---|
| 42227-081-01 | Cinryze | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 42 |
| 42227-083-01 | Cinryze | 1 in 1 CARTON | KIT | 1 | | 42 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HUMAN C1-ESTERASE INHIBITOR | ACTIVE INGREDIENT | 6KIC4BB60G | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| HUMAN C1-ESTERASE INHIBITOR | ACTIVE MOIETY | 6KIC4BB60G | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| ALANINE | INACTIVE INGREDIENT | OF5P57N2ZX | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| THREONINE | INACTIVE INGREDIENT | 2ZD004190S | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
| VALINE | INACTIVE INGREDIENT | HG18B9YRS7 | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VIROPHARMA BIOLOGICS] | 23 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42227-083 | CINRYZE (HUMAN C1-ESTERASE INHIBITOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CINRYZE (HUMAN C1-ESTERASE INHIBITOR) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 41 | Current NDC, Legacy NDC, 2 package rows | 20241224_d53a911f-070d-498a-8a61-baab72b9d0fe.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 |
|---|
| 42227-081-01 | 42227008101 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |
| 42227-083-01 | 42227008301 | 1 KIT in 1 CARTON (42227-083-01) * 5 mL in 1 VIAL, SINGLE-USE (42227-081-01) * 5 mL in 1 VIAL, GLASS (64764-515-50) | 1 kit | 2021-01-15 | 0000-00-00 | No | No | Current |