Loxapine

Product NDC: 67046-1479
Requested package NDC: 67046-1479-3
11-digit product format: 670461479
Labeler code: 67046
Product ID: 67046-1479_2cf84457-78c8-e60b-e063-6294a90a870b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loxapine
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA090695
Marketing category: ANDA
Marketing start: 2025-01-30
Substance: LOXAPINE SUCCINATE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loxapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOXAPINE SUCCINATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X59SG0MRYU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311386	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
d1b2bd99-c28a-46e0-9dad-cfbb5a5ed33e	Product name	1	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-1479-3	Loxapine	30 in 1 BLISTER PACK	CAPSULE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1479	LOXAPINE CAPSULE [COUPLER LLC]	1	Current NDC, 1 package rows	20250201_2cf83a3e-d76d-2a1f-e063-6294a90aa6bc.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 ndc (package): 67046-1479-3 ndc (product): 67046-1479 ndc11 (package): 67046147903
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311386	loxapine succinate 5 MG Oral Capsule	PSN	2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	1
311386	loxapine 5 MG Oral Capsule	SCD	2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	1
311386	loxapine 5 MG (as loxapine succinate 6.8 MG) Oral Capsule	SY	2cf83a3e-d76d-2a1f-e063-6294a90aa6bc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1479-3	67046147903	30 CAPSULE in 1 BLISTER PACK (67046-1479-3)	30 capsule	2025-01-30	No	No	Current