macrilen

Generic: macimorelin acetate

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name macrilen
Generic Name macimorelin acetate
Labeler novo nordisk
Dosage Form GRANULE, FOR SOLUTION
Routes
ORAL
Active Ingredients

macimorelin 60 mg/mg

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-1401
Product ID 0169-1401_ed003972-d498-43fc-b809-05a47d86b8da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205598
Marketing Start 2022-01-31
Marketing End 2027-02-28

Pharmacologic Class

Established (EPC)
growth hormone secretagogue receptor agonist [epc]
Mechanism of Action
growth hormone secretagogue receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01691401
Hyphenated Format 0169-1401

Supplemental Identifiers

UNII
8680B21W73
NUI
N0000193785 N0000193786

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 macrilen (source: ndc)
Generic Name macimorelin acetate (source: ndc)
Application Number NDA205598 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/mg
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH
source: ndc

Packages (1)

0169-1401-01 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH

Ingredients (1)

macimorelin (60 mg/mg)

Linked Drug Pages (1)

Macrilen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ed003972-d498-43fc-b809-05a47d86b8da", "openfda": {"nui": ["N0000193785", "N0000193786"], "unii": ["8680B21W73"], "spl_set_id": ["6034c9b8-5a36-4961-a5dd-11ebf7bdab78"], "pharm_class_epc": ["Growth Hormone Secretagogue Receptor Agonist [EPC]"], "pharm_class_moa": ["Growth Hormone Secretagogue Receptor Agonists [MoA]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0169-1401-01)  / 60 mg in 1 POUCH", "package_ndc": "0169-1401-01", "marketing_end_date": "20270228", "marketing_start_date": "20220131"}], "brand_name": "Macrilen", "product_id": "0169-1401_ed003972-d498-43fc-b809-05a47d86b8da", "dosage_form": "GRANULE, FOR SOLUTION", "pharm_class": ["Growth Hormone Secretagogue Receptor Agonist [EPC]", "Growth Hormone Secretagogue Receptor Agonists [MoA]"], "product_ndc": "0169-1401", "generic_name": "Macimorelin acetate", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Macrilen", "active_ingredients": [{"name": "MACIMORELIN", "strength": "60 mg/mg"}], "application_number": "NDA205598", "marketing_category": "NDA", "marketing_end_date": "20270228", "marketing_start_date": "20220131"}