FDA.reportPublic FDA data

Myalept

Product NDC
10122-210
11-digit product format
101220210
Labeler code
10122
Product ID
10122-210_8b236f4c-7654-49fe-bca9-ab947b72a1fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metreleptin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Chiesi USA, Inc.
Application
BLA125390
Marketing category
BLA
Marketing start
2015-03-05
Substance
METRELEPTIN
Active strength
11.3 mg/2.2mL
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Leptin Analog [EPC], Leptin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRELEPTIN11.3 mg/2.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TL60C27RLHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1491629Internal RxNorm lookup
1491634Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3b50bbd-140b-425c-b5ec-d4682aad62bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
454a5988-c452-4c4d-90ee-89badfa9b5dfProduct name120150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-210-02Myalept2.2 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,2.218
10122-210-02Myalept1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-210-02EA - Each10122-21031d6fd0d-24dc-4635-92e2-3e7d1cd062e812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-210MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.]18Current NDC, 2 package rows20250309_d3b50bbd-140b-425c-b5ec-d4682aad62bc.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
MyaleptMETRELEPTINChiesi USA, Inc.d3b50bbd-140b-425c-b5ec-d4682aad62bc2024-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125390
ndc (product): 10122-210

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125390Myaleptmetreleptin351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1491629metreleptin 5 MG/ML Injectable SolutionPSNd3b50bbd-140b-425c-b5ec-d4682aad62bc18
1491634myalept 5 MG/ML Injectable SolutionPSNd3b50bbd-140b-425c-b5ec-d4682aad62bc18
1491634metreleptin 5 MG/ML Injectable Solution [Myalept]SBDd3b50bbd-140b-425c-b5ec-d4682aad62bc18
1491629metreleptin 5 MG/ML Injectable SolutionSCDd3b50bbd-140b-425c-b5ec-d4682aad62bc18
1491629metreleptin 11.3 MG per 2.2 ML Injectable SolutionSYd3b50bbd-140b-425c-b5ec-d4682aad62bc18
1491634Myalept 11.3 MG per 2.2 ML Injectable SolutionSYd3b50bbd-140b-425c-b5ec-d4682aad62bc18
1491634Myalept 5 MG/ML Injectable SolutionSYd3b50bbd-140b-425c-b5ec-d4682aad62bc18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10122-210-02101220210021 VIAL, GLASS in 1 CARTON (10122-210-02) / 2.2 mL in 1 VIAL, GLASS2015-03-05NoNoCurrent