Propafenone Hydrochloride

Orange BookUNIISPLATC C01BC03

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeC01BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6068770901
100 BLISTER PACK in 1 CARTON (60687-709-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-709-11)

Annotations

UNII (FDA Substance ID)

33XCH0HOCD

PROPAFENONE HYDROCHLORIDE

RxCUI 203135

Orange Book

A075938

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": "60687-709_3f172eeb-8316-cdbc-e063-6394a90a1e86",
  "productndc": "60687-709",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075938",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Oct 17, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "002",
        "approval_date": "Oct 17, 2002"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Oct 17, 2002"
      }
    ],
    "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": "ANDA075938",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Propafenone Hydrochloride",
  "start_marketing_date": "20221013",
  "active_numerator_strength": "150"
}

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