🇺🇸
United States · US · US:51662-1363_ef7bd6e6-d62f-7e93-e053-2a95a90aef83
AMIODARONE HCI
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151662136313 mL in 1 VIAL, SINGLE-DOSE (51662-1363-1)
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": "51662-1363_ef7bd6e6-d62f-7e93-e053-2a95a90aef83",
"productndc": "51662-1363",
"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 HCI",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075761",
"marketing_category": "ANDA",
"nonproprietary_name": "AMIODARONE HCI",
"start_marketing_date": "20191208",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01BD01.
Access this data programmatically
Query AMIODARONE HCI 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.