lofexidine

Generic: lofexidine

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lofexidine
Generic Name lofexidine
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lofexidine hydrochloride .18 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-909
Product ID 70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219917
Listing Expiration 2026-12-31
Marketing Start 2025-10-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954909
Hyphenated Format 70954-909

Supplemental Identifiers

RxCUI
2046591
UPC
0370954909200 0370954909101
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 ANDA219917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .18 mg/1
source: ndc
Packaging
  • 36 TABLET in 1 BOTTLE (70954-909-10)
  • 96 TABLET in 1 BOTTLE (70954-909-20)
source: ndc

Packages (2)

70954-909-10 36 TABLET in 1 BOTTLE (70954-909-10) 70954-909-20 96 TABLET in 1 BOTTLE (70954-909-20)

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": "335e26bf-b236-46d6-81cf-2879e5f3b1d9", "openfda": {"upc": ["0370954909200", "0370954909101"], "unii": ["V47G1SDI1B"], "rxcui": ["2046591"], "spl_set_id": ["335e26bf-b236-46d6-81cf-2879e5f3b1d9"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "36 TABLET in 1 BOTTLE (70954-909-10)", "package_ndc": "70954-909-10", "marketing_start_date": "20251022"}, {"sample": false, "description": "96 TABLET in 1 BOTTLE (70954-909-20)", "package_ndc": "70954-909-20", "marketing_start_date": "20251022"}], "brand_name": "Lofexidine", "product_id": "70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9", "dosage_form": "TABLET", "product_ndc": "70954-909", "generic_name": "Lofexidine", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lofexidine", "active_ingredients": [{"name": "LOFEXIDINE HYDROCHLORIDE", "strength": ".18 mg/1"}], "application_number": "ANDA219917", "marketing_category": "ANDA", "marketing_start_date": "20251022", "listing_expiration_date": "20261231"}