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United States · US · US:67877-455_f4ed6589-2062-48b0-8a0c-25b0342342c2

Finasteride

In shortageOrange BookUNIISPLATC G04CB01

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

Identification

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

Packs · 4

  • ndc11
    6787745505
    500 TABLET, COATED in 1 BOTTLE (67877-455-05)
  • ndc11
    6787745530
    30 TABLET, COATED in 1 BOTTLE (67877-455-30)
  • ndc11
    6787745590
    90 TABLET, COATED in 1 BOTTLE (67877-455-90)
  • ndc11
    6787745594
    3 BLISTER PACK in 1 CARTON (67877-455-94) / 10 TABLET, COATED in 1 BLISTER PACK (67877-455-34)

Annotations

UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
A207750
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": "67877-455_f4ed6589-2062-48b0-8a0c-25b0342342c2",
  "productndc": "67877-455",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "207750",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jan 6, 2017"
      }
    ],
    "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": "ANDA207750",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Finasteride",
  "start_marketing_date": "20170106",
  "active_numerator_strength": "1"
}

Related drugs

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