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United States · US · US:72205-246_19b5c932-af2d-4a0b-ac4a-ba06c53c3219

lofexidine hydrochloride

Orange BookUNIISPLATC N07BC04

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeN07BC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7220524642
    1 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7220524643
    1 BOTTLE in 1 CARTON (72205-246-43) / 96 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
V47G1SDI1B
LOFEXIDINE HYDROCHLORIDE
RxCUI 235853
Orange Book
A218699
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": "72205-246_19b5c932-af2d-4a0b-ac4a-ba06c53c3219",
  "productndc": "72205-246",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218699",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.18MG BASE",
        "product_no": "001",
        "approval_date": "Feb 24, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOFEXIDINE HYDROCHLORIDE",
  "proprietary_name": "lofexidine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218699",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lofexidine hydrochloride",
  "start_marketing_date": "20250224",
  "active_numerator_strength": ".2"
}

Related drugs

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