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United States · US · US:57483-165_7f6c711d-2ee7-46d5-8b2c-4cf643bff18e

REGOXIDINE (FOR MEN)

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

  • ndc11
    5748316511
    1 CAN in 1 CARTON (57483-165-11) / 60 g in 1 CAN (57483-165-01)
  • ndc11
    5748316513
    3 CAN in 1 CARTON (57483-165-13) / 60 g in 1 CAN (57483-165-01)

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": "57483-165_7f6c711d-2ee7-46d5-8b2c-4cf643bff18e",
  "productndc": "57483-165",
  "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 MEN)",
  "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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