Home NDC 70954-909 Lofexidine
Product NDC 70954-909
11-digit product format 709540909
Labeler code 70954
Product ID 70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lofexidine
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA219917
Marketing category ANDA
Marketing start 2025-10-22
Substance LOFEXIDINE HYDROCHLORIDE
Active strength .18 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219917-001 LOFEXIDINE HYDROCHLORIDE LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2025-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219917-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219917-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2025-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219917-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2025-10-22 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219917-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2025-10-22 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219917-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219917-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219917-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Lofexidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOFEXIDINE HYDROCHLORIDE .18 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V47G1SDI1B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2046591 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-909-10 Lofexidine 36 in 1 BOTTLE TABLET 36 1 70954-909-20 Lofexidine 96 in 1 BOTTLE TABLET 96 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-909-10 70954090910 36 TABLET in 1 BOTTLE (70954-909-10) 36 tablet 2025-10-22 No No Current 70954-909-20 70954090920 96 TABLET in 1 BOTTLE (70954-909-20) 96 tablet 2025-10-22 No No Current