Loxapine

Product NDC: 50090-4701
11-digit product format: 500904701
Labeler code: 50090
Product ID: 50090-4701_95f9466d-3982-4892-9a24-e8d1c2d3b7d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loxapine
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090695
Marketing category: ANDA
Marketing start: 2011-09-26
Marketing end: 0000-00-00
Substance: LOXAPINE SUCCINATE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-4701		D	Discontinued by firm		2026-08-10
excluded package	package	50090-4701	50090-4701-0	D	Discontinued by firm		2026-08-10

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4701-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4701-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-4701-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-4701-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-4701-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-4701-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-4701-0	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-4701-0	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-4701-0	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-4701-0	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-4701-0	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-4701-0	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4701-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4701-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4701-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090695-001	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26
A090695-002	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26
A090695-003	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26
A090695-004	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090695-001	AB
A090695-002	AB
A090695-003	AB
A090695-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090695-001	LOXAPINE SUCCINATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090695-002	LOXAPINE SUCCINATE	EQ 10MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090695-003	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090695-004	LOXAPINE SUCCINATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2011-09-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090695-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090695-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090695-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090695-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090695-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090695-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090695-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090695-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090695-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090695-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090695-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090695-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090695-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4701-0	2025-04-15	C162847	48780-1	1030e365-096c-111a-e063-dadaa90a10e2	Loxapine Capsules, USP
50090-4701-0	2024-01-30	C162847	48780-1	1030e365-096c-111a-e063-dadaa90a10e2	Loxapine Capsules, USP

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loxapine	LOXAPINE	REMEDYREPACK INC.	832ce6b1-5846-4a5b-adb4-ac4e0f502d78	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	REMEDYREPACK INC.	2d45dd3c-71c3-4cc1-92ac-6dcecb195dd2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	REMEDYREPACK INC.	74ac619f-216b-4a79-b23a-158f4e44d25d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Chartwell RX, LLC	3e412c36-66b0-444b-833b-cea79976844e	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Coupler LLC	2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Coupler LLC	2cf85ba7-7b62-6519-e063-6394a90a32c4	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Coupler LLC	2ce01a5d-b9bc-af4d-e063-6394a90af9e4	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Lannett Company, Inc.	509bad3c-b563-4042-b270-d28bde19f224	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695
Loxapine	LOXAPINE	Proficient Rx LP	3fa7b9c3-f500-49d5-b0c5-27ff01779713	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090695 application number: ANDA090695

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X59SG0MRYU	LOXAPINE SUCCINATE	27833-64-3	LOXAPINE SUCCINATE
LER583670J	LOXAPINE	1977-10-2	Loxapine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4701-0	50090470100	1 BOX, UNIT-DOSE in 1 BLISTER PACK (50090-4701-0) > 32 CAPSULE in 1 BOX, UNIT-DOSE	2019-11-08	0000-00-00	No	No	Current