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United States · US · US:23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fc
Ibutilide Fumarate
Orange BookUNIISPLATC C01BD05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC01BD05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1123155326311 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
9L5X4M5L6I
IBUTILIDE FUMARATE
RxCUI 51256
Orange Book
A204146
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9L5X4M5L6I",
"rxcui": "51256",
"inchikey": "PCIOHQNIRPWFMV-WXXKFALUSA-N",
"display_name": "IBUTILIDE FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd0": {
"match": "brand_token",
"title": "IBUTILIDE FUMARATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fc",
"productndc": "23155-326",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "204146",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.1MG/ML",
"product_no": "001",
"approval_date": "Apr 1, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUTILIDE FUMARATE",
"proprietary_name": "Ibutilide Fumarate",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA204146",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibutilide Fumarate",
"start_marketing_date": "20240401",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C01BD05.
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