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United States · US · US:0169-1401_ed003972-d498-43fc-b809-05a47d86b8da
Macrilen
Orange BookUNIISPLATC V04CD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovo Nordisk
CountryUS (United States)
ATC codeV04CD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101691401011 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH
Annotations
UNII (FDA Substance ID)
8680B21W73
MACIMORELIN
RxCUI 1999420
Orange Book
N205598
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8680B21W73",
"rxcui": "1999420",
"inchikey": "UJVDJAPJQWZRFR-DHIUTWEWSA-N",
"display_name": "MACIMORELIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aeb30f1a-4815-47ae-a2cb-b6b4e26372e1": {
"match": "brand_token",
"title": "MACRILEN (MACIMORELIN ACETATE) GRANULE, FOR SOLUTION [AETERNA ZENTARIS GMBH]",
"spl_version": "3",
"published_date": "2026-02-19"
}
},
"productid": "0169-1401_ed003972-d498-43fc-b809-05a47d86b8da",
"productndc": "0169-1401",
"dosage_form": "GRANULE, FOR SOLUTION",
"orange_book": {
"appl_no": "205598",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE/POUCH",
"product_no": "001",
"approval_date": "Dec 20, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MACIMORELIN",
"proprietary_name": "Macrilen",
"active_ingred_unit": "mg/mg",
"application_number": "NDA205598",
"marketing_category": "NDA",
"nonproprietary_name": "Macimorelin acetate",
"start_marketing_date": "20220131",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code V04CD06.
- NOGhryvelinAtnahs Pharma Netherlands B.V.
- DKGHRYVELINAtnahs Pharma Netherlands B.V.
- ISGHRYVELINAtnahs Pharma Netherlands B.V.
- PLGHRYVELINAtnahs Pharma Netherlands B.V.
- FIGHRYVELINAtnahs Pharma Netherlands B.V.
- CZGHRYVELINAtnahs Pharma Netherlands B.V., Amsterdam
- BEGhryvelin 60 mgAtnahs Pharma Netherlands
- NLGHRYVELIN 60 mg granulaat voor orale suspensie in sachetAtnahs Pharma Netherlands B.V.
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