🇺🇸
United States · US · US:57483-175_40d86d45-ccc6-4b7e-a152-453469b21379
REGOXIDINE (FOR WOMEN)
Orange BookUNIISPLATC C02DC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerINNOVUS PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeC02DC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1157483175111 CAN in 1 CARTON (57483-175-11) / 60 g in 1 CAN (57483-175-01)
- ndc1157483175122 CAN in 1 CARTON (57483-175-12) / 60 g in 1 CAN (57483-175-01)
Annotations
UNII (FDA Substance ID)
5965120SH1
MINOXIDIL
RxCUI 6984
Orange Book
A218616
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5965120SH1",
"rxcui": "6984",
"inchikey": "ZFMITUMMTDLWHR-UHFFFAOYSA-N",
"display_name": "MINOXIDIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"9c06c34d-5a09-47ed-b969-cc81f4ed61ab": {
"match": "brand_token",
"title": "REGOXIDINE (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [INNOVUS PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2026-01-21"
}
},
"productid": "57483-175_40d86d45-ccc6-4b7e-a152-453469b21379",
"productndc": "57483-175",
"dosage_form": "AEROSOL, FOAM",
"orange_book": {
"appl_no": "218616",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5%",
"product_no": "001",
"approval_date": "Apr 22, 2024"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5%",
"product_no": "002",
"approval_date": "Apr 22, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "MINOXIDIL",
"proprietary_name": "REGOXIDINE (FOR WOMEN)",
"active_ingred_unit": "mg/g",
"application_number": "ANDA218616",
"marketing_category": "ANDA",
"nonproprietary_name": "MINOXIDIL",
"start_marketing_date": "20250503",
"active_numerator_strength": "50"
}Related drugs
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