LOFEXIDINE

Product NDC: 85789-901
11-digit product format: 857890901
Labeler code: 85789
Product ID: 85789-901_5e7a0c1b-828c-f3d4-e063-6394a90a4b43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lofexidine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: BioCorRx Pharmaceuticals Inc
Application: NDA209229
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-08-15
Substance: LOFEXIDINE HYDROCHLORIDE
Active strength: .2 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 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	N209229-001	LUCEMYRA	EQ 0.18MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209229-001	LUCEMYRA	EQ 0.18MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209229-001	LUCEMYRA	EQ 0.18MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-16	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N209229-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209229-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209229-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: LOFEXIDINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOFEXIDINE HYDROCHLORIDE	.2 mg/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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lofexidine hydrochloride	LOFEXIDINE HYDROCHLORIDE	Prasco Laboratories	77367dfa-434f-4d61-95fe-f0f1628457d1	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209229 application number: NDA209229
LUCEMYRA	LOFEXIDINE HYDROCHLORIDE	BioCorRx Pharmaceuticals Inc	0a848cc2-4dda-40d9-8b01-d789fe8981ed	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209229 application number: NDA209229
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

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	Marketing start	Sample	Exclude flag	Status
85789-901-36	85789090136	36 TABLET, FILM COATED in 1 BOTTLE (85789-901-36)	2026-08-15	No	No	Current
85789-901-96	85789090196	96 TABLET, FILM COATED in 1 BOTTLE (85789-901-96)	2026-08-15	No	No	Current