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United States · US · US:70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9
Lofexidine
Orange BookUNIISPLATC N07BC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN07BC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11709549091036 TABLET in 1 BOTTLE (70954-909-10)
- ndc11709549092096 TABLET in 1 BOTTLE (70954-909-20)
Annotations
UNII (FDA Substance ID)
V47G1SDI1B
LOFEXIDINE HYDROCHLORIDE
RxCUI 235853
Orange Book
A219917
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": "70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9",
"productndc": "70954-909",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219917",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.18MG BASE",
"product_no": "001",
"approval_date": "Oct 22, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOFEXIDINE HYDROCHLORIDE",
"proprietary_name": "Lofexidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219917",
"marketing_category": "ANDA",
"nonproprietary_name": "Lofexidine",
"start_marketing_date": "20251022",
"active_numerator_strength": ".18"
}Related drugs
Other records sharing ATC code N07BC04.
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