Cinryze
- Product NDC
- 42227-081
- 11-digit product format
- 422270081
- Labeler code
- 42227
- Product ID
- 42227-081_421ea216-278f-4ca8-ae5d-5dafe85658a0
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN C1-ESTERASE INHIBITOR
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA125267
- Marketing category
- BLA
- Marketing start
- 2008-12-01
- Substance
- HUMAN C1-ESTERASE INHIBITOR
- Active strength
- 500 [iU]/5mL
- Pharmacologic classes
- Decreased Vascular Permeability [PE], Human C1 Esterase Inhibitor [EPC], Kallikrein Inhibitors [MoA]
- 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
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN C1-ESTERASE INHIBITOR | 500 [iU]/5mL |
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 |
| 42227-081-01 | Cinryze | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 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 |
|---|
| 42227-081 | 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, 1 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 (42227-081-01) | 5 ml | 2008-12-01 | | No | No | Current |
| 42227-081-05 | 42227008105 | 1 VIAL, SINGLE-USE in 1 CARTON (42227-081-05) > 5 mL in 1 VIAL, SINGLE-USE (42227-081-01) | | 2008-12-01 | 0000-00-00 | No | No | Current |