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United States · US · US:71921-250_f742254f-781e-4e7a-ae0b-e79b8482980d
Lofexidine
Orange BookUNIISPLATC N07BC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeN07BC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1171921250361 BOTTLE in 1 CARTON (71921-250-36) / 36 TABLET, COATED in 1 BOTTLE
- ndc1171921250961 BOTTLE in 1 CARTON (71921-250-96) / 96 TABLET, COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
V47G1SDI1B
LOFEXIDINE HYDROCHLORIDE
RxCUI 235853
Orange Book
A218613
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": "71921-250_f742254f-781e-4e7a-ae0b-e79b8482980d",
"productndc": "71921-250",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "218613",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.18MG BASE",
"product_no": "001",
"approval_date": "Aug 20, 2024"
}
],
"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": "ANDA218613",
"marketing_category": "ANDA",
"nonproprietary_name": "Lofexidine",
"start_marketing_date": "20240821",
"active_numerator_strength": ".18"
}Related drugs
Other records sharing ATC code N07BC04.
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