🇺🇸
United States · US · US:58844-130_4b196948-f481-3bd6-e063-6394a90aaae1
Macrilen
Orange BookUNIISPLATC V04CD06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAeterna Zentaris GmbH
CountryUS (United States)
ATC codeV04CD06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158844130011 POUCH in 1 CARTON (58844-130-01) / 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": "58844-130_4b196948-f481-3bd6-e063-6394a90aaae1",
"productndc": "58844-130",
"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/1817mg",
"application_number": "NDA205598",
"marketing_category": "NDA",
"nonproprietary_name": "Macimorelin acetate",
"start_marketing_date": "20180129",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code V04CD06.
- NOGhryvelinAtnahs Pharma Netherlands B.V.
- ISGHRYVELINAtnahs Pharma Netherlands B.V.
- DKGHRYVELINAtnahs Pharma Netherlands B.V.
- FIGHRYVELINAtnahs Pharma Netherlands B.V.
- PLGHRYVELINAtnahs 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.
Access this data programmatically
Query Macrilen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.