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United States · US · US:71610-787_f373ed89-c786-4f7c-a55e-2d1dc62971b0
Pacerone
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11716107873030 TABLET in 1 BOTTLE (71610-787-30)
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A075135
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": {
"dcadce9c-d0a0-4235-8ff8-dd93c09e03b3": {
"match": "brand_token",
"title": "PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]",
"spl_version": "101",
"published_date": "2025-11-17"
}
},
"productid": "71610-787_f373ed89-c786-4f7c-a55e-2d1dc62971b0",
"productndc": "71610-787",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075135",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Apr 30, 1998"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Apr 12, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Jul 2, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIODARONE HYDROCHLORIDE",
"proprietary_name": "Pacerone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075135",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiodarone Hydrochloride",
"start_marketing_date": "20101115",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C01BD01.
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