🇺🇸
United States · US · US:72495-401_2b9876fb-e9e0-4dbc-e063-6294a90a8696
Intrarosa
Orange BookUNIISPLATC A14AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMillicent US, Inc.
CountryUS (United States)
ATC codeA14AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172495401281 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
459AG36T1B
PRASTERONE
RxCUI 3143
Orange Book
N208470
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "459AG36T1B",
"rxcui": "3143",
"inchikey": "FMGSKLZLMKYGDP-USOAJAOKSA-N",
"display_name": "PRASTERONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"spl_meta": {
"ada639d4-bac0-2ad0-e053-2a95a90afce7": {
"match": "brand_token",
"title": "INTRAROSA (PRASTERONE) INSERT [MILLICENT US, INC.]",
"spl_version": "5",
"published_date": "2025-01-14"
}
},
"productid": "72495-401_2b9876fb-e9e0-4dbc-e063-6294a90a8696",
"productndc": "72495-401",
"dosage_form": "INSERT",
"orange_book": {
"appl_no": "208470",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "6.5MG",
"product_no": "001",
"approval_date": "Nov 16, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRASTERONE",
"proprietary_name": "Intrarosa",
"active_ingred_unit": "mg/1",
"application_number": "NDA208470",
"marketing_category": "NDA",
"nonproprietary_name": "Prasterone",
"start_marketing_date": "20201101",
"active_numerator_strength": "6.5"
}Related drugs
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