Lucemyra

Product NDC: 27505-050
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	27505-050		D	Discontinued by firm	2026-08-03
excluded package	package	27505-050	27505-050-03	D	Discontinued by firm	2026-08-03
excluded package	package	27505-050	27505-050-36	D	Discontinued by firm	2026-08-03
excluded package	package	27505-050	27505-050-96	D	Discontinued by firm	2026-08-03

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	27505-050-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	27505-050-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	27505-050-36	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	27505-050-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	27505-050-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	27505-050-36	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	27505-050-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	27505-050-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	27505-050-36	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	27505-050-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	27505-050-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	27505-050-36	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	27505-050-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	27505-050-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	27505-050-36	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	27505-050-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	27505-050-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	27505-050-36	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	27505-050-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	27505-050-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	27505-050-36	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	27505-050-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	27505-050-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	27505-050-36	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	27505-050-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	27505-050-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	27505-050-36	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	27505-050-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	27505-050-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	27505-050-36	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	27505-050-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	27505-050-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	27505-050-36	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	27505-050-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	27505-050-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	27505-050-36	`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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209229-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209229-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209229-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209229-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209229-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209229-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209229-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209229-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209229-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209229-001	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209229-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209229-001	NCE	2023-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209229-001	NCE	2023-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209229-001	NCE	2023-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209229-001	NCE	2023-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209229-001	NCE	2023-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209229-001	NCE	2023-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209229-001	NCE	2023-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209229-001	NCE	2023-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209229-001	NCE	2023-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209229-001	NCE	2023-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209229-001	NCE	2023-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209229-001	NCE	2023-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209229-001	NCE	2023-05-16	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N209229-001	NCE	2023-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209229-001	NCE	2023-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209229-001	NCE	2023-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209229-001	NCE	2023-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209229-001	NCE	2023-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209229-001	NCE	2023-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209229-001	NCE	2023-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209229-001	NCE	2023-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209229-001	NCE	2023-05-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209229-001	NCE	2023-05-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209229-001	NCE	2023-05-16	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27505-050-36	EA - Each	27505-050	1387aaea-3d84-4560-996d-3621b2131769	1	2018-06-11
27505-050-96	EA - Each	27505-050	22ba32b9-3137-4704-b22f-a5cef80fb0f5	1	2018-06-11

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lucemyra	LOFEXIDINE HYDROCHLORIDE	USWM, LLC	b748f308-ba71-4fd9-84ec-ec7e0f210885	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209229 application number: NDA209229
Lofexidine hydrochloride	LOFEXIDINE HYDROCHLORIDE	Prasco Laboratories	77367dfa-434f-4d61-95fe-f0f1628457d1	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209229 application number: NDA209229

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V47G1SDI1B	LOFEXIDINE HYDROCHLORIDE	21498-08-8	LOFEXIDINE HYDROCHLORIDE

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
27505-050-36	27505005036	1 BOTTLE in 1 CARTON (27505-050-36) > 36 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2018-06-18	0000-00-00	No	No	Current
27505-050-96	27505005096	1 BOTTLE in 1 CARTON (27505-050-96) > 96 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2018-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lucemyra	US WorldMeds, LLC \| SGS Life Science Services \| Acceleration Laboratory Services, Inc. \| Apace Packaging LLC \| Helsinn Advanced Synthesis SA \| UFAG Laboratoriien AG \| Catalent Pharma Solutions, LLC \| A+ Secrure Packaging, LLC \| Helsinn Birex Pharmaceuticals LTD	2021-11-02	HUMAN PRESCRIPTION DRUG LABEL	6