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United States · US · US:66993-345_b317fb7f-8a02-4d11-9d20-401644e5d6ef

Lofexidine hydrochloride

Orange BookUNIISPLATC N07BC04

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

Identification

ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeN07BC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6699334537
    1 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    6699334576
    1 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
V47G1SDI1B
LOFEXIDINE HYDROCHLORIDE
RxCUI 235853
Orange Book
N209229
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V47G1SDI1B",
    "rxcui": "235853",
    "inchikey": "DWWHMKBNNNZGHF-UHFFFAOYSA-N",
    "display_name": "LOFEXIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ce4488e2-842c-45ba-aca7-075a900e2a1c": {
      "match": "brand_token",
      "title": "LOFEXIDINE TABLET, COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]",
      "spl_version": "3",
      "published_date": "2026-05-22"
    }
  },
  "productid": "66993-345_b317fb7f-8a02-4d11-9d20-401644e5d6ef",
  "productndc": "66993-345",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209229",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.18MG BASE",
        "product_no": "001",
        "approval_date": "May 16, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOFEXIDINE HYDROCHLORIDE",
  "proprietary_name": "Lofexidine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209229",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "lofexidine hydrochloride",
  "start_marketing_date": "20240829",
  "active_numerator_strength": ".2"
}

Related drugs

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