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United States · US · US:68682-011_4c621e16-3dbb-4774-935e-69270e52fe8e
ethacrynic acid
Orange BookUNIISPLATC C03CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeC03CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116868201110100 TABLET in 1 BOTTLE (68682-011-10)
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": {
"b9bc3907-bfa7-4d9f-90d9-c2097230f7e4": {
"match": "brand_token",
"title": "ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]",
"spl_version": "6",
"published_date": "2026-04-27"
}
},
"productid": "68682-011_4c621e16-3dbb-4774-935e-69270e52fe8e",
"productndc": "68682-011",
"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": "ethacrynic acid",
"active_ingred_unit": "mg/1",
"application_number": "NDA016092",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "ethacrynic acid",
"start_marketing_date": "19670110",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03CC01.
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