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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
- ndc1166993345371 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLE
- ndc1166993345761 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
Other records sharing ATC code N07BC04.
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