Home NDC 71921-250-96 Lofexidine
Product NDC 71921-250
Requested package NDC 71921-250-96
11-digit product format 719210250
Labeler code 71921
Product ID 71921-250_f742254f-781e-4e7a-ae0b-e79b8482980d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lofexidine
Dosage form TABLET, COATED
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA218613
Marketing category ANDA
Marketing start 2024-08-21
Substance LOFEXIDINE HYDROCHLORIDE
Active strength .18 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 A218613-001 LOFEXIDINE HYDROCHLORIDE LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218613-001 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 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218613-001 LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB 2024-08-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218613-001 CGT 2025-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218613-001 CGT 2025-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218613-001 CGT 2025-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218613-001 CGT 2025-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218613-001 CGT 2025-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218613-001 CGT 2025-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218613-001 CGT 2025-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218613-001 CGT 2025-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218613-001 CGT 2025-02-24 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Lofexidine
Listing expiration 2027-12-31 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 71921-250-36 Lofexidine 1 in 1 CARTON TABLET, COATED 1 3 71921-250-36 Lofexidine 36 in 1 BOTTLE TABLET, COATED 36 3 71921-250-96 Lofexidine 96 in 1 BOTTLE TABLET, COATED 96 3 71921-250-96 Lofexidine 1 in 1 CARTON TABLET, COATED 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71921-250 LOFEXIDINE TABLET, COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] 1 Current NDC, 4 package rows 20240822_ce4488e2-842c-45ba-aca7-075a900e2a1c.zip
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 · 2 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 71921-250-96 71921025096 1 BOTTLE in 1 CARTON (71921-250-96) / 96 TABLET, COATED in 1 BOTTLE 1 bottle 2024-08-21 No No Current