🇺🇸
United States · US · US:25010-215_4c442b87-1bbd-40e6-8c40-004f5f46e996
EDECRIN
Orange BookUNIISPLATC C03CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeC03CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc112501021515100 TABLET in 1 BOTTLE (25010-215-15)
Annotations
UNII (FDA Substance ID)
M5DP350VZV
ETHACRYNIC ACID
RxCUI 4109
Orange Book
N016092
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M5DP350VZV",
"rxcui": "4109",
"inchikey": "AVOLMBLBETYQHX-UHFFFAOYSA-N",
"display_name": "ETHACRYNIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8": {
"match": "brand_token",
"title": "EDECRIN (ETHACRYNIC ACID) TABLET SODIUM EDECRIN (ETHACRYNATE SODIUM) POWDER, FOR SOLUTION [BAUSCH HEALTH US, LLC]",
"spl_version": "10",
"published_date": "2024-08-06"
}
},
"productid": "25010-215_4c442b87-1bbd-40e6-8c40-004f5f46e996",
"productndc": "25010-215",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "016092",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHACRYNIC ACID",
"proprietary_name": "EDECRIN",
"active_ingred_unit": "mg/1",
"application_number": "NDA016092",
"marketing_category": "NDA",
"nonproprietary_name": "ethacrynic acid",
"start_marketing_date": "19670110",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03CC01.
Access this data programmatically
Query EDECRIN and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.