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United States · US · US:72673-071_487d000e-9dec-3e6f-e063-6294a90ae8b0
Amiodarone Hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZhejiang Poly Pharm. Co., Ltd.
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172673071103 mL in 1 VIAL, GLASS (72673-071-10)
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A218253
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": "72673-071_487d000e-9dec-3e6f-e063-6294a90ae8b0",
"productndc": "72673-071",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218253",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Sep 11, 2024"
}
],
"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": "ANDA218253",
"marketing_category": "ANDA",
"nonproprietary_name": "amiodarone hydrochloride",
"start_marketing_date": "20230206",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01BD01.
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