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United States · US · US:65219-643_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a
Amiodarone Hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11652196430325 VIAL, SINGLE-DOSE in 1 TRAY (65219-643-03) / 3 mL in 1 VIAL, SINGLE-DOSE (65219-643-01)
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A075761
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "976728SY6Z",
"rxcui": "203114",
"inchikey": "ITPDYQOUSLNIHG-UHFFFAOYSA-N",
"display_name": "AMIODARONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f4532f12-3b7a-42ab-9a6c-36fd2a3f192c": {
"match": "brand_token",
"title": "AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-25"
}
},
"productid": "65219-643_9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a",
"productndc": "65219-643",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "075761",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Oct 15, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIODARONE HYDROCHLORIDE",
"proprietary_name": "Amiodarone Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075761",
"marketing_category": "ANDA",
"nonproprietary_name": "AMIODARONE HYDROCHLORIDE",
"start_marketing_date": "20250505",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01BD01.
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