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United States · US · US:64380-184_42f443a0-4884-4ff2-a480-57b1aaaa5b06

Propafenone Hydrochloride

Orange BookUNIISPLATC C01BC03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeC01BC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6438018401
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-01)
  • ndc11
    6438018402
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-02)
  • ndc11
    6438018404
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64380-184-04)

Annotations

UNII (FDA Substance ID)
33XCH0HOCD
PROPAFENONE HYDROCHLORIDE
RxCUI 203135
Orange Book
A078540
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": "64380-184_42f443a0-4884-4ff2-a480-57b1aaaa5b06",
  "productndc": "64380-184",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078540",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG",
        "product_no": "002",
        "approval_date": "Oct 18, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "425MG",
        "product_no": "003",
        "approval_date": "Oct 18, 2010"
      }
    ],
    "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": "ANDA078540",
  "marketing_category": "ANDA",
  "nonproprietary_name": "propafenone hydrochloride",
  "start_marketing_date": "20220404",
  "active_numerator_strength": "225"
}

Related drugs

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