lofexidine hydrochloride

Generic: lofexidine hydrochloride

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name lofexidine hydrochloride
Generic Name lofexidine hydrochloride
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lofexidine hydrochloride .2 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-345
Product ID 66993-345_b317fb7f-8a02-4d11-9d20-401644e5d6ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA209229
Listing Expiration 2026-12-31
Marketing Start 2024-08-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993345
Hyphenated Format 66993-345

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 hydrochloride (source: ndc)
Generic Name lofexidine hydrochloride (source: ndc)
Application Number NDA209229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .2 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

66993-345-37 1 BOTTLE in 1 CARTON (66993-345-37) / 36 TABLET, FILM COATED in 1 BOTTLE 66993-345-76 1 BOTTLE in 1 CARTON (66993-345-76) / 96 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

lofexidine hydrochloride (.2 mg/1)

Linked Drug Pages (1)

Lofexidine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b317fb7f-8a02-4d11-9d20-401644e5d6ef", "openfda": {"unii": ["V47G1SDI1B"], "rxcui": ["2046591"], "spl_set_id": ["77367dfa-434f-4d61-95fe-f0f1628457d1"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66993-345-37)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66993-345-37", "marketing_start_date": "20240829"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (66993-345-76)  / 96 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "66993-345-76", "marketing_start_date": "20240829"}], "brand_name": "Lofexidine hydrochloride", "product_id": "66993-345_b317fb7f-8a02-4d11-9d20-401644e5d6ef", "dosage_form": "TABLET, FILM COATED", "product_ndc": "66993-345", "generic_name": "lofexidine hydrochloride", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lofexidine hydrochloride", "active_ingredients": [{"name": "LOFEXIDINE HYDROCHLORIDE", "strength": ".2 mg/1"}], "application_number": "NDA209229", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240829", "listing_expiration_date": "20261231"}