FDA.reportPublic FDA data

Myalept

Product NDC
76431-210
11-digit product format
764310210
Labeler code
76431
Product ID
76431-210_d02c8a27-7501-4b03-bf87-43f4948f11a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metreleptin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Amryt Pharmaceuticals DAC
Application
BLA125390
Marketing category
BLA
Marketing start
2015-03-05
Marketing end
0000-00-00
Substance
METRELEPTIN
Active strength
11 mg/2.2mL
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Leptin Analog [EPC], Leptin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76431-210DDiscontinued by firm2026-08-17
excluded packagepackage76431-21076431-210-01DDiscontinued by firm2026-08-17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76431-210-01EA - Each76431-210a788f0fb-c5e1-44f5-9d8f-1f5b32a1404112016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MetreleptinACTIVE INGREDIENTTL60C27RLHMYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.]4
MetreleptinACTIVE MOIETYTL60C27RLHMYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.]4
Glutamic AcidINACTIVE INGREDIENT3KX376GY7LMYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.]4
GlycineINACTIVE INGREDIENTTE7660XO1CMYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.]4
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHMYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.]4
SucroseINACTIVE INGREDIENTC151H8M554MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AEGERION PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76431-210MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMRYT PHARMACEUTICALS DESIGNATED ACTIVITY COMPANY]14Legacy NDC20250228_c986f93b-855d-4ef0-b620-5d41a0513e48.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

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76431-210-01764310210011 VIAL, GLASS in 1 CARTON (76431-210-01) > 2.2 mL in 1 VIAL, GLASS2015-03-050000-00-00NoNoCurrent