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NDC 10122-0180-02 Lamzede 10 mg/1 Details
Lamzede 10 mg/1
Lamzede is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chiesi USA, Inc.. The primary component is VELMANASE ALFA-TYCV.
MedlinePlus Drug Summary
Velmanase alfa is used to treat certain symptoms associated with alpha-mannosidosis (a genetic condition where the body is unable to break down complex sugars). Velmanase alfa is in a class of medications called recombinant lysosomal enzymes. It works by breaking down mannose-containing oligosaccharides, a complex sugar, that can build up in people with alpha-mannosidosis and cause toxicity to many of the body's tissues.
Related Packages: 10122-0180-02Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Velmanase alfa
Product Information
| NDC | 10122-0180 |
|---|---|
| Product ID | 10122-180_27cf090b-196e-4330-8184-c72d9bb90660 |
| Associated GPIs | |
| GCN Sequence Number | 080623 |
| GCN Sequence Number Description | velmanase alfa-tycv VIAL 10 MG INTRAVEN |
| HIC3 | Z1X |
| HIC3 Description | METABOLIC DX ENZYME REPLACEMENT,ALPHA-MANNOSIDOSIS |
| GCN | 47541 |
| HICL Sequence Number | 046263 |
| HICL Sequence Number Description | VELMANASE ALFA-TYCV |
| Brand/Generic | Brand |
| Proprietary Name | Lamzede |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Velmanase alfa-tycv |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | VELMANASE ALFA-TYCV |
| Labeler Name | Chiesi USA, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761278 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10122-0180-02 (10122018002)
| NDC Package Code | 10122-180-02 |
|---|---|
| Billing NDC | 10122018002 |
| Package | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02) |
| Marketing Start Date | 2023-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |