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United States · US · US:58604-214_1d1d7ef0-7a05-41c3-849f-6f1778863a73
ADDYI
Orange BookUNIISPLATC G02CX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSprout Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158604214301 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
37JK4STR6Z
FLIBANSERIN
RxCUI 1665509
Orange Book
N022526
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "37JK4STR6Z",
"rxcui": "1665509",
"inchikey": "PPRRDFIXUUSXRA-UHFFFAOYSA-N",
"display_name": "FLIBANSERIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3819daf3-e935-2c53-c527-e1d57922f394": {
"match": "brand_token",
"title": "ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.]",
"spl_version": "15",
"published_date": "2025-12-23"
}
},
"productid": "58604-214_1d1d7ef0-7a05-41c3-849f-6f1778863a73",
"productndc": "58604-214",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022526",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 18, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLIBANSERIN",
"proprietary_name": "ADDYI",
"active_ingred_unit": "mg/1",
"application_number": "NDA022526",
"marketing_category": "NDA",
"nonproprietary_name": "flibanserin",
"start_marketing_date": "20150818",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CX02.
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