myalept

Generic: metreleptin

Labeler: amryt pharmaceuticals designated activity company
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name myalept
Generic Name metreleptin
Labeler amryt pharmaceuticals designated activity company
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

metreleptin 11.3 mg/2.2mL

Manufacturer
Amryt Pharmaceuticals Designated Activity Company

Identifiers & Regulatory

Product NDC 76431-210
Product ID 76431-210_5654fc72-b7ad-420b-8173-f65ad5add4d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125390
Listing Expiration 2026-12-31
Marketing Start 2015-03-05

Pharmacologic Class

Established (EPC)
leptin analog [epc]
Chemical Structure
analogs/derivatives [chemical/ingredient] leptin [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76431210
Hyphenated Format 76431-210

Supplemental Identifiers

RxCUI
1491629 1491634
UNII
TL60C27RLH
NUI
N0000190854 N0000175452 N0000170333

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 myalept (source: ndc)
Generic Name metreleptin (source: ndc)
Application Number BLA125390 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 11.3 mg/2.2mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (76431-210-01) / 2.2 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

76431-210-01 1 VIAL, GLASS in 1 CARTON (76431-210-01) / 2.2 mL in 1 VIAL, GLASS

Ingredients (1)

metreleptin (11.3 mg/2.2mL)

Linked Drug Pages (1)

Myalept ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "5654fc72-b7ad-420b-8173-f65ad5add4d3", "openfda": {"nui": ["N0000190854", "N0000175452", "N0000170333"], "unii": ["TL60C27RLH"], "rxcui": ["1491629", "1491634"], "spl_set_id": ["c986f93b-855d-4ef0-b620-5d41a0513e48"], "pharm_class_cs": ["Analogs/Derivatives [Chemical/Ingredient]", "Leptin [Chemical/Ingredient]"], "pharm_class_epc": ["Leptin Analog [EPC]"], "manufacturer_name": ["Amryt Pharmaceuticals Designated Activity Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (76431-210-01)  / 2.2 mL in 1 VIAL, GLASS", "package_ndc": "76431-210-01", "marketing_start_date": "20150305"}], "brand_name": "Myalept", "product_id": "76431-210_5654fc72-b7ad-420b-8173-f65ad5add4d3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "Leptin Analog [EPC]", "Leptin [Chemical/Ingredient]"], "product_ndc": "76431-210", "generic_name": "metreleptin", "labeler_name": "Amryt Pharmaceuticals Designated Activity Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myalept", "active_ingredients": [{"name": "METRELEPTIN", "strength": "11.3 mg/2.2mL"}], "application_number": "BLA125390", "marketing_category": "BLA", "marketing_start_date": "20150305", "listing_expiration_date": "20261231"}