Loxapine

Product NDC: 70518-0347
11-digit product format: 705180347
Labeler code: 70518
Product ID: 70518-0347_e158add0-1f78-19b9-e053-2995a90a558c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loxapine
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA072206
Marketing category: ANDA
Marketing start: 2017-03-21
Marketing end: 0000-00-00
Substance: LOXAPINE SUCCINATE
Active strength: 25 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0347		D	Discontinued by firm	2026-08-10
excluded package	package	70518-0347	70518-0347-0	D	Discontinued by firm	2026-08-10
excluded package	package	70518-0347	70518-0347-1	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 · 33 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	70518-0347-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0347-1	`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	70518-0347-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0347-1	`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	70518-0347-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0347-1	`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	70518-0347-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0347-1	`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	70518-0347-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0347-1	`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	70518-0347-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0347-1	`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	70518-0347-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0347-1	`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	70518-0347-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0347-1	`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	70518-0347-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0347-1	`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	70518-0347-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0347-1	`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	70518-0347-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0347-1	`367a005e9d99…`	`383a685ebd0f…`

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
A072206-001	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072206-001	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	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072206-001	LOXAPINE SUCCINATE	EQ 25MG BASE	CAPSULE / ORAL	AB	RS	1988-06-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A072206-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072206-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072206-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072206-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072206-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072206-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072206-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072206-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072206-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072206-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072206-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072206-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072206-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072206-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072206-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072206-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072206-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072206-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072206-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072206-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072206-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072206-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072206-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072206-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072206-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072206-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072206-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072206-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072206-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072206-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072206-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072206-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072206-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072206-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072206-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072206-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072206-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072206-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072206-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072206-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loxapine	LOXAPINE	Actavis Pharma, Inc.	a6107bb1-3e23-4c5d-bbf4-5e29deff6728	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072206 application number: ANDA072206

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0347-0	70518034700	30 CAPSULE in 1 BLISTER PACK (70518-0347-0)	30 capsule	2017-03-21	0000-00-00	No	No	Current