Loxapine

Product NDC: 10135-588
11-digit product format: 101350588
Labeler code: 10135
Product ID: 10135-588_42bcc296-c005-416f-b0ad-2dccc0c8fe46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loxapine succinate
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA090695
Marketing category: ANDA
Marketing start: 2014-10-01
Marketing end: 0000-00-00
Substance: LOXAPINE SUCCINATE
Active strength: 50 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-588		I	Inactivated by FDA	2026-08-10
excluded package	package	10135-588	10135-588-01	I	Inactivated by FDA	2026-08-10
excluded package	package	10135-588	10135-588-10	I	Inactivated by FDA	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 2 · 66 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	10135-588-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-588-01	`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	10135-588-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-588-01	`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	10135-588-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-588-01	`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	10135-588-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-588-01	`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	10135-588-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-588-01	`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	10135-588-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-588-01	`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	10135-588-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-588-01	`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	10135-588-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-588-01	`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	10135-588-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-588-01	`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	10135-588-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-588-01	`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	10135-588-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-588-01	`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	10135-588-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-588-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-588-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-588-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-588-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-588-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-588-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-588-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-588-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-588-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-588-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-588-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-588-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-588-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-588-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-588-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10135-588-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10135-588-01	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33e	Product name	1	20201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-588-01	2020-01-31	C162847	48780-1	9d75b9d0-06d9-f424-e053-dadaa90a57ce	Loxapine Tablet
10135-588-10	2020-01-31	C162847	48780-1	9d75b9d0-06d9-f424-e053-dadaa90a57ce	Loxapine Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-588-01	Loxapine	100 in 1 BOTTLE	TABLET	100		1
10135-588-10	Loxapine	1000 in 1 BOTTLE	TABLET	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-588-01	EA - Each	10135-588	593925db-b936-437d-b38f-2fcb3b71e7be	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-588	LOXAPINE (LOXAPINE SUCCINATE) TABLET [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 2 package rows	20160210_dee2537b-1bd8-42f6-990f-62359e646822.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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-588-01	10135058801	100 in 1 BOTTLE	Historical
10135-588-10	10135058810	1000 in 1 BOTTLE	Historical