Propafenone Hydrochloride

Orange BookUNIISPLATC C01BC03

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeC01BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0832074260
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0742-60)

Annotations

UNII (FDA Substance ID)

33XCH0HOCD

PROPAFENONE HYDROCHLORIDE

RxCUI 203135

Orange Book

A212744

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": "0832-0742_45afbac0-5c1a-ebc5-e063-6294a90a4d5e",
  "productndc": "0832-0742",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212744",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "001",
        "approval_date": "Jun 25, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG",
        "product_no": "002",
        "approval_date": "Jun 25, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "425MG",
        "product_no": "003",
        "approval_date": "Jun 25, 2020"
      }
    ],
    "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": "ANDA212744",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Propafenone Hydrochloride",
  "start_marketing_date": "20200625",
  "active_numerator_strength": "425"
}

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