PROPAFENONE HYDROCHLORIDE

Orange BookUNIISPLATC C01BC03

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

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeC01BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1657173606
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-06)
ndc11
1657173650
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16571-736-50)

Annotations

UNII (FDA Substance ID)

33XCH0HOCD

PROPAFENONE HYDROCHLORIDE

RxCUI 203135

Orange Book

A205956

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": "16571-736_36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8",
  "productndc": "16571-736",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205956",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "001",
        "approval_date": "Jul 2, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG",
        "product_no": "002",
        "approval_date": "Jul 2, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "425MG",
        "product_no": "003",
        "approval_date": "Jul 2, 2018"
      }
    ],
    "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": "ANDA205956",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PROPAFENONE HYDROCHLORIDE",
  "start_marketing_date": "20201216",
  "active_numerator_strength": "225"
}

Related drugs

Other records sharing ATC code C01BC03.

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