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United States · US · US:85097-576_2b43c093-2e44-fc04-e063-6394a90a1907

Stafenit Hair Regrowth Treatment Topical Minoxidil

Orange BookUNIISPLATC C02DC01

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

Identification

ManufacturerCozesmo
CountryUS (United States)
ATC codeC02DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8509757600
    1 BOTTLE, DROPPER in 1 BOX (85097-576-00) / 60 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
5965120SH1
MINOXIDIL
RxCUI 6984
Orange Book
A076239
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": {
    "cd74cc10-6df4-47bf-885e-333244db6d82": {
      "match": "brand_token",
      "title": "STAFENIT HAIR REGROWTH TREATMENT TOPICAL MINOXIDIL (MINOXIDIL) SOLUTION [COZESMO]",
      "spl_version": "1",
      "published_date": "2025-01-13"
    }
  },
  "productid": "85097-576_2b43c093-2e44-fc04-e063-6394a90a1907",
  "productndc": "85097-576",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076239",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Aug 24, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MINOXIDIL",
  "proprietary_name": "Stafenit Hair Regrowth Treatment Topical Minoxidil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076239",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MINOXIDIL",
  "start_marketing_date": "20241211",
  "active_numerator_strength": "50"
}

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