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ELAPRASE
ELAPRASE - 54092-700-01 - (idursulfase)
Drug Information of ELAPRASE
| Product NDC: | 54092-700 |
| Proprietary Name: | ELAPRASE |
| Non Proprietary Name: | idursulfase |
| Active Ingredient(s): | 6 mg/3mL & nbsp; idursulfase |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | SOLUTION, CONCENTRATE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of ELAPRASE
| Product NDC: | 54092-700 |
| Labeler Name: | Shire US Manufacturing Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125151 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20060724 |
Package Information of ELAPRASE
| Package NDC: | 54092-700-01 |
| Package Description: | 1 VIAL, GLASS in 1 BOX (54092-700-01) > 3 mL in 1 VIAL, GLASS |
NDC Information of ELAPRASE
| NDC Code | 54092-700-01 |
| Proprietary Name | ELAPRASE |
| Package Description | 1 VIAL, GLASS in 1 BOX (54092-700-01) > 3 mL in 1 VIAL, GLASS |
| Product NDC | 54092-700 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | idursulfase |
| Dosage Form Name | SOLUTION, CONCENTRATE |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20060724 |
| Marketing Category Name | BLA |
| Labeler Name | Shire US Manufacturing Inc. |
| Substance Name | IDURSULFASE |
| Strength Number | 6 |
| Strength Unit | mg/3mL |
| Pharmaceutical Classes | alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] |
