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NDC 58468-0040-01 Fabrazyme 5 mg/mL Details
Fabrazyme 5 mg/mL
Fabrazyme 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 AGALSIDASE BETA.
Product Information
| NDC | 58468-0040 |
|---|---|
| Product ID | 58468-0040_3a3c1bad-6f7f-4300-8aa4-b4cfe8d0fc57 |
| Associated GPIs | 30903610102120 |
| GCN Sequence Number | 051658 |
| GCN Sequence Number Description | agalsidase beta VIAL 35 MG INTRAVEN |
| HIC3 | Z1H |
| HIC3 Description | METABOLIC DISEASE ENZYME REPLACEMENT, FABRY'S DX |
| GCN | 18997 |
| HICL Sequence Number | 024861 |
| HICL Sequence Number Description | AGALSIDASE BETA |
| Brand/Generic | Brand |
| Proprietary Name | Fabrazyme |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AGALSIDASE BETA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | AGALSIDASE BETA |
| Labeler Name | Genzyme Corporation |
| Pharmaceutical Class | Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC], alpha-Glucosidases [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103979 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58468-0040-01 (58468004001)
| NDC Package Code | 58468-0040-1 |
|---|---|
| Billing NDC | 58468004001 |
| Package | 1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2008-12-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |