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United States · US · US:69616-264_8e502b8a-7d2d-476b-8516-6678cfefbe32
AGAMREE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCatalyst Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169616264381 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38)
Annotations
Orange Book
N215239
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"fb376f09-cf9c-42b5-b4dd-02d5bcd73211": {
"match": "brand_token",
"title": "AGAMREE (VAMOROLONE) KIT [CATALYST PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-04-08"
}
},
"productid": "69616-264_8e502b8a-7d2d-476b-8516-6678cfefbe32",
"productndc": "69616-264",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "215239",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Oct 26, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "AGAMREE",
"active_ingred_unit": null,
"application_number": "NDA215239",
"marketing_category": "NDA",
"nonproprietary_name": "VAMOROLONE",
"start_marketing_date": "20240201",
"active_numerator_strength": null
}Access this data programmatically
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