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NDC 42227-0081-05 Cinryze 500 [iU]/5mL Details
Cinryze 500 [iU]/5mL
Cinryze is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is HUMAN C1-ESTERASE INHIBITOR.
Product Information
| NDC | 42227-0081 |
|---|---|
| Product ID | 42227-081_696969cf-1588-4eec-9874-7de096db04dd |
| Associated GPIs | 85802022002120 |
| GCN Sequence Number | 040429 |
| GCN Sequence Number Description | C1 esterase inhibitor VIAL 500 (5 ML) INTRAVEN |
| HIC3 | M0N |
| HIC3 Description | C1 ESTERASE INHIBITORS |
| GCN | 10495 |
| HICL Sequence Number | 018568 |
| HICL Sequence Number Description | C1 ESTERASE INHIBITOR |
| Brand/Generic | Brand |
| Proprietary Name | Cinryze |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HUMAN C1-ESTERASE INHIBITOR |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | [iU]/5mL |
| Substance Name | HUMAN C1-ESTERASE INHIBITOR |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Decreased Vascular Permeability [PE], Human C1 Esterase Inhibitor [EPC], Kallikrein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125267 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42227-0081-05 (42227008105)
| NDC Package Code | 42227-081-05 |
|---|---|
| Billing NDC | 42227008105 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (42227-081-05) / 5 mL in 1 VIAL, SINGLE-USE (42227-081-01) |
| Marketing Start Date | 2008-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |