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United States · US · US:51672-4056_4cc4c3cb-aced-a125-e063-6394a90aee93
Amiodarone Hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115167240561100 TABLET in 1 BOTTLE (51672-4056-1)
- ndc1151672405631000 TABLET in 1 BOTTLE (51672-4056-3)
- ndc11516724056630 TABLET in 1 BOTTLE (51672-4056-6)
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A076362
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": "ORAL",
"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": "51672-4056_4cc4c3cb-aced-a125-e063-6394a90aee93",
"productndc": "51672-4056",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076362",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "400MG",
"product_no": "001",
"approval_date": "Nov 29, 2002"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG",
"product_no": "002",
"approval_date": "Dec 2, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIODARONE HYDROCHLORIDE",
"proprietary_name": "Amiodarone Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076362",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiodarone Hydrochloride",
"start_marketing_date": "20031202",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code C01BD01.
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