🇺🇸
United States · US · US:71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6
Amiodarone Hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117133519421200 TABLET in 1 BOTTLE (71335-1942-1)
- ndc11713351942230 TABLET in 1 BOTTLE (71335-1942-2)
- ndc11713351942360 TABLET in 1 BOTTLE (71335-1942-3)
- ndc11713351942490 TABLET in 1 BOTTLE (71335-1942-4)
- ndc11713351942510 TABLET in 1 BOTTLE (71335-1942-5)
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A213446
AB
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": "71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6",
"productndc": "71335-1942",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213446",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jul 21, 2020"
}
],
"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": "ANDA213446",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiodarone Hydrochloride",
"start_marketing_date": "20200901",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C01BD01.
Access this data programmatically
Query Amiodarone Hydrochloride 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.