FDA.reportPublic FDA data

Lamzede

Product NDC
10122-180
11-digit product format
101220180
Labeler code
10122
Product ID
10122-180_27cf090b-196e-4330-8184-c72d9bb90660
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Velmanase alfa-tycv
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Chiesi USA, Inc.
Application
BLA761278
Marketing category
BLA
Marketing start
2023-03-01
Substance
VELMANASE ALFA-TYCV
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamzede
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VELMANASE ALFA-TYCV10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M91TG242P2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2630729Internal RxNorm lookup
2630734Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
36d50a08-60bd-40eb-807c-778d69bf2d2eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-180-02Lamzede1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
10122-180-05Lamzede5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,51
10122-180-10Lamzede10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-180-02EA - Each10122-18097787090-b498-4faa-83df-a3410002d6a512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-180LAMZEDE (VELMANASE ALFA-TYCV) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.]1Current NDC, 3 package rows20230301_36d50a08-60bd-40eb-807c-778d69bf2d2e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamzedeVELMANASE ALFA-TYCVChiesi USA, Inc.36d50a08-60bd-40eb-807c-778d69bf2d2e2023-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761278
ndc (product): 10122-180

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761278Lamzedevelmanase alfa-tycv351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630734Lamzede 10 MG InjectionPSN36d50a08-60bd-40eb-807c-778d69bf2d2e1
2630729velmanase alfa-tycv 10 MG InjectionPSN36d50a08-60bd-40eb-807c-778d69bf2d2e1
2630734velmanase alfa-tycv 10 MG Injection [Lamzede]SBD36d50a08-60bd-40eb-807c-778d69bf2d2e1
2630729velmanase alfa-tycv 10 MG InjectionSCD36d50a08-60bd-40eb-807c-778d69bf2d2e1
2630734Lamzede 10 MG InjectionSY36d50a08-60bd-40eb-807c-778d69bf2d2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10122-180-02101220180021 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02) 2023-03-01NoNoCurrent
10122-180-05101220180055 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-05) 2023-03-01NoNoCurrent
10122-180-101012201801010 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-10) 2023-03-01NoNoCurrent