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United States · US · US:78206-152_97f5deb0-a4ab-42c3-afa0-db2170a16297

PROPECIA

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeG04CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7820615201
    30 TABLET, FILM COATED in 1 BOTTLE (78206-152-01)
  • ndc11
    7820615202
    90 TABLET, FILM COATED in 1 BOTTLE (78206-152-02)

Annotations

UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
N020788
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Finasteride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "57GNO57U7G",
    "rxcui": "25025",
    "inchikey": "DBEPLOCGEIEOCV-WSBQPABSSA-N",
    "display_name": "FINASTERIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6f904709-65aa-44ce-b144-b4c8a0416e36": {
      "match": "brand_token",
      "title": "PROPECIA (FINASTERIDE) TABLET, FILM COATED [ORGANON LLC]",
      "spl_version": "9",
      "published_date": "2024-10-14"
    }
  },
  "productid": "78206-152_97f5deb0-a4ab-42c3-afa0-db2170a16297",
  "productndc": "78206-152",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020788",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Dec 19, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINASTERIDE",
  "shortage_reason": "Finasteride Tablet",
  "shortage_status": "current",
  "proprietary_name": "PROPECIA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020788",
  "marketing_category": "NDA",
  "nonproprietary_name": "finasteride",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code G04CB01.

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