lofexidine hydrochloride

Generic: lofexidine hydrochloride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lofexidine hydrochloride
Generic Name lofexidine hydrochloride
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lofexidine hydrochloride .2 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-246
Product ID 72205-246_19b5c932-af2d-4a0b-ac4a-ba06c53c3219
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218699
Listing Expiration 2026-12-31
Marketing Start 2025-02-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205246
Hyphenated Format 72205-246

Supplemental Identifiers

RxCUI
2046591
UPC
0372205246430 0372205246423
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 ANDA218699 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .2 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72205-246-43) / 96 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

72205-246-42 1 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLE 72205-246-43 1 BOTTLE in 1 CARTON (72205-246-43) / 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": "19b5c932-af2d-4a0b-ac4a-ba06c53c3219", "openfda": {"upc": ["0372205246430", "0372205246423"], "unii": ["V47G1SDI1B"], "rxcui": ["2046591"], "spl_set_id": ["19b5c932-af2d-4a0b-ac4a-ba06c53c3219"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72205-246-42)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72205-246-42", "marketing_start_date": "20250301"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72205-246-43)  / 96 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72205-246-43", "marketing_start_date": "20250301"}], "brand_name": "lofexidine hydrochloride", "product_id": "72205-246_19b5c932-af2d-4a0b-ac4a-ba06c53c3219", "dosage_form": "TABLET, FILM COATED", "product_ndc": "72205-246", "generic_name": "lofexidine hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lofexidine hydrochloride", "active_ingredients": [{"name": "LOFEXIDINE HYDROCHLORIDE", "strength": ".2 mg/1"}], "application_number": "ANDA218699", "marketing_category": "ANDA", "marketing_start_date": "20250224", "listing_expiration_date": "20261231"}