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 Identifiers#

Field, Values table
FieldValues
UniiTL60C27RLH
Rxcui1491629, 1491634

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

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, GLASS2015-03-05NoNoHistorical