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NDC 58468-0051-01 XENPOZYME 4 mg/1.1mL Details
XENPOZYME 4 mg/1.1mL
XENPOZYME is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Genzyme Corporation. The primary component is OLIPUDASE ALFA.
Product Information
| NDC | 58468-0051 |
|---|---|
| Product ID | 58468-0051_30470c72-f91b-4074-99d6-3d5e265b1542 |
| Associated GPIs | |
| GCN Sequence Number | 085089 |
| GCN Sequence Number Description | olipudase alfa-rpcp VIAL 4 MG INTRAVEN |
| HIC3 | Z14 |
| HIC3 Description | METABOLIC DISEASE ENZYME REPLACEMENT, ASMD |
| GCN | 54528 |
| HICL Sequence Number | 048267 |
| HICL Sequence Number Description | OLIPUDASE ALFA-RPCP |
| Brand/Generic | Brand |
| Proprietary Name | XENPOZYME |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | olipudase alfa-rpcp |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | mg/1.1mL |
| Substance Name | OLIPUDASE ALFA |
| Labeler Name | Genzyme Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761261 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58468-0051-01 (58468005101)
| NDC Package Code | 58468-0051-1 |
|---|---|
| Billing NDC | 58468005101 |
| Package | 1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL |
| Marketing Start Date | 2022-08-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |