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United States · US · US:85407-001_310cc524-7b0b-7a14-e063-6294a90af192

Hair Regrowth Treatment

Orange BookUNIISPLATC C02DC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDongguan yiyu trading co., ltd
CountryUS (United States)
ATC codeC02DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8540700101
    100 mL in 1 BOTTLE (85407-001-01)

Annotations

UNII (FDA Substance ID)
5965120SH1
MINOXIDIL
RxCUI 6984
Orange Book
A209074
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": {
    "eb87ff2d-7708-4c4d-e053-2a95a90ac72b": {
      "match": "brand_token",
      "title": "HAIR REGROWTH TREATMENT (MINOXIDIL) LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY.CO.,LTD]",
      "spl_version": "4",
      "published_date": "2026-05-26"
    }
  },
  "productid": "85407-001_310cc524-7b0b-7a14-e063-6294a90af192",
  "productndc": "85407-001",
  "dosage_form": "LIQUID",
  "orange_book": {
    "appl_no": "209074",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Dec 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "002",
        "approval_date": "Apr 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MINOXIDIL",
  "proprietary_name": "Hair Regrowth Treatment",
  "active_ingred_unit": "g/100mL",
  "application_number": "ANDA209074",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hair Regrowth Treatment",
  "start_marketing_date": "20250321",
  "active_numerator_strength": "5"
}

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