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United States · US · US:65841-631_aabb5533-5d41-49a3-b8b6-14627af57311
Amiodarone hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116584163105500 TABLET in 1 BOTTLE (65841-631-05)
- ndc11658416310630 TABLET in 1 BOTTLE (65841-631-06)
- ndc1165841631101000 TABLET in 1 BOTTLE (65841-631-10)
- ndc11658416311460 TABLET in 1 BOTTLE (65841-631-14)
- ndc11658416317710 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A079029
ABABAB
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": "65841-631_aabb5533-5d41-49a3-b8b6-14627af57311",
"productndc": "65841-631",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079029",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Sep 16, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Jan 6, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Jan 6, 2023"
}
],
"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": "ANDA079029",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiodarone hydrochloride",
"start_marketing_date": "20090810",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C01BD01.
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