lofexidine

Generic: lofexidine

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lofexidine
Generic Name lofexidine
Labeler florida pharmaceutical products, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

lofexidine hydrochloride .18 mg/1

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-250
Product ID 71921-250_ce4488e2-842c-45ba-aca7-075a900e2a1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218613
Listing Expiration 2026-12-31
Marketing Start 2024-08-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921250
Hyphenated Format 71921-250

Supplemental Identifiers

RxCUI
2046591
UNII
V47G1SDI1B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lofexidine (source: ndc)
Generic Name lofexidine (source: ndc)
Application Number ANDA218613 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .18 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71921-250-36) / 36 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (71921-250-96) / 96 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (2)

71921-250-36 1 BOTTLE in 1 CARTON (71921-250-36) / 36 TABLET, COATED in 1 BOTTLE 71921-250-96 1 BOTTLE in 1 CARTON (71921-250-96) / 96 TABLET, COATED in 1 BOTTLE

Ingredients (1)

lofexidine hydrochloride (.18 mg/1)

Linked Drug Pages (1)

Lofexidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ce4488e2-842c-45ba-aca7-075a900e2a1c", "openfda": {"unii": ["V47G1SDI1B"], "rxcui": ["2046591"], "spl_set_id": ["ce4488e2-842c-45ba-aca7-075a900e2a1c"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71921-250-36)  / 36 TABLET, COATED in 1 BOTTLE", "package_ndc": "71921-250-36", "marketing_start_date": "20240821"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (71921-250-96)  / 96 TABLET, COATED in 1 BOTTLE", "package_ndc": "71921-250-96", "marketing_start_date": "20240821"}], "brand_name": "Lofexidine", "product_id": "71921-250_ce4488e2-842c-45ba-aca7-075a900e2a1c", "dosage_form": "TABLET, COATED", "product_ndc": "71921-250", "generic_name": "Lofexidine", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lofexidine", "active_ingredients": [{"name": "LOFEXIDINE HYDROCHLORIDE", "strength": ".18 mg/1"}], "application_number": "ANDA218613", "marketing_category": "ANDA", "marketing_start_date": "20240821", "listing_expiration_date": "20261231"}