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United States · US · US:78670-050_0be33ddd-71d6-45b7-85ce-e665789911ba

Lucemyra

Orange BookUNIISPLATC N07BC04

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

Identification

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

Packs · 3

  • ndc11
    7867005003
    1 BOTTLE in 1 CARTON (78670-050-03) / 36 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7867005036
    1 BOTTLE in 1 CARTON (78670-050-36) / 36 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7867005096
    1 BOTTLE in 1 CARTON (78670-050-96) / 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": {
    "b748f308-ba71-4fd9-84ec-ec7e0f210885": {
      "match": "brand_token",
      "title": "LUCEMYRA (LOFEXIDINE HYDROCHLORIDE) TABLET, FILM COATED [USWM, LLC]",
      "spl_version": "9",
      "published_date": "2026-01-23"
    }
  },
  "productid": "78670-050_0be33ddd-71d6-45b7-85ce-e665789911ba",
  "productndc": "78670-050",
  "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": "Lucemyra",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209229",
  "marketing_category": "NDA",
  "nonproprietary_name": "lofexidine hydrochloride",
  "start_marketing_date": "20210209",
  "active_numerator_strength": ".2"
}

Related drugs

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