lamzede

Generic: velmanase alfa-tycv

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name lamzede
Generic Name velmanase alfa-tycv
Labeler chiesi usa, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

velmanase alfa-tycv 10 mg/1

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-180
Product ID 10122-180_27cf090b-196e-4330-8184-c72d9bb90660
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761278
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122180
Hyphenated Format 10122-180

Supplemental Identifiers

RxCUI
2630729 2630734
UNII
M91TG242P2

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lamzede (source: ndc)
Generic Name velmanase alfa-tycv (source: ndc)
Application Number BLA761278 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02)
  • 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-05)
  • 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-10)
source: ndc

Packages (3)

10122-180-02 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02) 10122-180-05 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-05) 10122-180-10 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-10)

Ingredients (1)

velmanase alfa-tycv (10 mg/1)

Linked Drug Pages (1)

Lamzede ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "27cf090b-196e-4330-8184-c72d9bb90660", "openfda": {"unii": ["M91TG242P2"], "rxcui": ["2630729", "2630734"], "spl_set_id": ["36d50a08-60bd-40eb-807c-778d69bf2d2e"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02)", "package_ndc": "10122-180-02", "marketing_start_date": "20230301"}, {"sample": false, "description": "5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-05)", "package_ndc": "10122-180-05", "marketing_start_date": "20230301"}, {"sample": false, "description": "10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-10)", "package_ndc": "10122-180-10", "marketing_start_date": "20230301"}], "brand_name": "Lamzede", "product_id": "10122-180_27cf090b-196e-4330-8184-c72d9bb90660", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "10122-180", "generic_name": "Velmanase alfa-tycv", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamzede", "active_ingredients": [{"name": "VELMANASE ALFA-TYCV", "strength": "10 mg/1"}], "application_number": "BLA761278", "marketing_category": "BLA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}