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United States · US · US:71335-0881_a148ddb8-adb0-46dc-90ed-7df37af2a4ce
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
- ndc117133508811200 TABLET in 1 BOTTLE (71335-0881-1)
- ndc11713350881230 TABLET in 1 BOTTLE (71335-0881-2)
- ndc11713350881360 TABLET in 1 BOTTLE (71335-0881-3)
- ndc11713350881490 TABLET in 1 BOTTLE (71335-0881-4)
- ndc11713350881510 TABLET in 1 BOTTLE (71335-0881-5)
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A075424
ABAB
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": "71335-0881_a148ddb8-adb0-46dc-90ed-7df37af2a4ce",
"productndc": "71335-0881",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075424",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Mar 30, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Dec 18, 2002"
}
],
"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": "ANDA075424",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiodarone Hydrochloride",
"start_marketing_date": "20010330",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C01BD01.
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