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United States · US · US:72162-2148_b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0
Pacerone
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 · 1
- ndc11721622148330 TABLET in 1 BOTTLE (72162-2148-3)
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": "72162-2148_b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0",
"productndc": "72162-2148",
"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": "100"
}Related drugs
Other records sharing ATC code C01BD01.
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