Home NDC 27505-050-03 Lucemyra
Product NDC 27505-050
Requested package NDC 27505-050-03
11-digit product format 275050050
Labeler code 27505
Product ID 27505-050_cfcfad0f-e591-bfd6-e053-2995a90a0cef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lofexidine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler US WorldMeds, LLC
Application NDA209229
Marketing category NDA
Marketing start 2018-06-18
Marketing end 0000-00-00
Substance LOFEXIDINE HYDROCHLORIDE
Active strength 0 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N209229-001 LUCEMYRA LOFEXIDINE HYDROCHLORIDE EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209229-001 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.
Product history page 1 of 2 · 41 observed 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 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL AB RLD, RS 2018-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209229-001 LUCEMYRA EQ 0.18MG BASE TABLET / ORAL RLD, RS 2018-05-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27505-050-03 27505005003 1 BOTTLE in 1 CARTON (27505-050-03) > 36 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-06-18 0000-00-00 Yes No Current