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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
- ndc1172205246421 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLE
- ndc1172205246431 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
Other records sharing ATC code N07BC04.
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