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United States · US · US:59651-276_ef0c975d-08ee-4649-9017-4f7f1a2981a1
Propafenone Hydrochloride
Orange BookUNIISPLATC C01BC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC01BC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115965127605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-276-05)
- ndc11596512766060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-276-60)
- ndc11596512769090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-276-90)
Annotations
UNII (FDA Substance ID)
33XCH0HOCD
PROPAFENONE HYDROCHLORIDE
RxCUI 203135
Orange Book
A213096
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "33XCH0HOCD",
"rxcui": "203135",
"inchikey": "XWIHRGFIPXWGEF-UHFFFAOYSA-N",
"display_name": "PROPAFENONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c65253ab-937f-4982-b841-69c2b9f9ccdb": {
"match": "brand_token",
"title": "PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "59651-276_ef0c975d-08ee-4649-9017-4f7f1a2981a1",
"productndc": "59651-276",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213096",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "225MG",
"product_no": "001",
"approval_date": "Feb 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "325MG",
"product_no": "002",
"approval_date": "Feb 21, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "425MG",
"product_no": "003",
"approval_date": "Feb 21, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPAFENONE HYDROCHLORIDE",
"proprietary_name": "Propafenone Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213096",
"marketing_category": "ANDA",
"nonproprietary_name": "Propafenone Hydrochloride",
"start_marketing_date": "20230221",
"active_numerator_strength": "225"
}Related drugs
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Access this data programmatically
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