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United States · US · US:70518-1704_52bdaf45-db8c-a733-e063-6394a90a3121
Finasteride
In shortageOrange BookUNIISPLATC G04CB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeG04CB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117051817042100 POUCH in 1 BOX (70518-1704-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-1704-3)
Annotations
UNII (FDA Substance ID)
57GNO57U7G
FINASTERIDE
RxCUI 25025
Orange Book
A078341
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": "70518-1704_52bdaf45-db8c-a733-e063-6394a90a3121",
"productndc": "70518-1704",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078341",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Oct 30, 2007"
}
],
"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": "ANDA078341",
"marketing_category": "ANDA",
"nonproprietary_name": "Finasteride",
"start_marketing_date": "20181130",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04CB01.
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