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United States · US · US:69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cf
ETHACRYNATE SODIUM
Orange BookUNIISPLATC C03CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeC03CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169315701501 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
K41MYV7MPM
ETHACRYNATE SODIUM
RxCUI 4108
Orange Book
A208663
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K41MYV7MPM",
"rxcui": "4108",
"inchikey": "CWCSCNSKBSCYCS-UHFFFAOYSA-M",
"display_name": "ETHACRYNATE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"e24e7440-a958-6fd0-6bfe-1bd29e638657": {
"match": "brand_token",
"title": "ETHACRYNATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LEADING PHARMA, LLC]",
"spl_version": "3",
"published_date": "2026-01-16"
}
},
"productid": "69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cf",
"productndc": "69315-701",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "208663",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 9, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHACRYNATE SODIUM",
"proprietary_name": "ETHACRYNATE SODIUM",
"active_ingred_unit": "mg/50mL",
"application_number": "ANDA208663",
"marketing_category": "ANDA",
"nonproprietary_name": "ETHACRYNATE SODIUM",
"start_marketing_date": "20260109",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C03CC01.
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