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United States · US · US:0904-6830_d1f34c55-de1d-48a5-af38-06cbea8c6b8d

Finasteride

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

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

Packs · 2

  • ndc11
    0904683006
    50 BLISTER PACK in 1 CARTON (0904-6830-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0904683061
    100 BLISTER PACK in 1 CARTON (0904-6830-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
A090061
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": {
    "da4e8a51-cf1c-4018-976f-edecc4934a39": {
      "match": "brand_token",
      "title": "FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0904-6830_d1f34c55-de1d-48a5-af38-06cbea8c6b8d",
  "productndc": "0904-6830",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090061",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 7, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINASTERIDE",
  "shortage_reason": "Finasteride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Finasteride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090061",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Finasteride",
  "start_marketing_date": "20150613",
  "active_numerator_strength": "5"
}

Related drugs

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