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NDC 44206-0454-04 Hizentra 0.2 g/mL Details
Hizentra 0.2 g/mL
Hizentra is a SUBCUTANEOUS LIQUID in the PLASMA DERIVATIVE category. It is labeled and distributed by CSL Behring AG. The primary component is HUMAN IMMUNOGLOBULIN G.
Product Information
| NDC | 44206-0454 |
|---|---|
| Product ID | 44206-454_411c01a7-0ae7-45d2-8b4c-cbe99a2ba264 |
| Associated GPIs | 19100020202058 |
| GCN Sequence Number | 066167 |
| GCN Sequence Number Description | immun glob G(IgG)/pro/IgA 0-50 VIAL 4 G/20 ML SUBCUT |
| HIC3 | W7K |
| HIC3 Description | ANTISERA |
| GCN | 28387 |
| HICL Sequence Number | 041798 |
| HICL Sequence Number Description | IMMUNE GLOBULIN,GAMMA (IGG)/PROLINE/IGA 0 TO 50 MCG/ML |
| Brand/Generic | Brand |
| Proprietary Name | Hizentra |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HUMAN IMMUNOGLOBULIN G |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | LIQUID |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 0.2 |
| Active Ingredient Units | g/mL |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Labeler Name | CSL Behring AG |
| Pharmaceutical Class | Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125350 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 44206-0454-04 (44206045404)
| NDC Package Code | 44206-454-04 |
|---|---|
| Billing NDC | 44206045404 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (44206-454-04) / 20 mL in 1 VIAL, SINGLE-DOSE (44206-454-92) |
| Marketing Start Date | 2011-10-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |