Propafenone Hydrochloride

Orange BookUNIISPLATC C01BC03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC01BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5965127805
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05)
ndc11
5965127860
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-60)
ndc11
5965127890
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-90)

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": "59651-278_ef0c975d-08ee-4649-9017-4f7f1a2981a1",
  "productndc": "59651-278",
  "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": "425"
}

Related drugs

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