Loxapine

Product NDC: 0527-1396
11-digit product format: 005271396
Labeler code: 0527
Product ID: 0527-1396_d237714b-55f8-4a6e-9297-c10d41ab3cd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loxapine
Dosage form: CAPSULE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA090695
Marketing category: ANDA
Marketing start: 2011-09-26
Substance: LOXAPINE SUCCINATE
Active strength: 25 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	25 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311385	Internal RxNorm lookup
311386	Internal RxNorm lookup
314075	Internal RxNorm lookup
314078	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
509bad3c-b563-4042-b270-d28bde19f224	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
0527-1396-01	Loxapine	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		20
0527-1396-10	Loxapine	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1396-01	EA - Each	0527-1396	3af29670-9b88-4e0f-a1ff-27a0ab4f757a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOXAPINE SUCCINATE	ACTIVE INGREDIENT	X59SG0MRYU	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
LOXAPINE	ACTIVE MOIETY	LER583670J	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1396	LOXAPINE CAPSULE [LANNETT COMPANY, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20241120_509bad3c-b563-4042-b270-d28bde19f224.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 ndc (product): 0527-1396
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
314078	loxapine succinate 10 MG Oral Capsule	PSN	509bad3c-b563-4042-b270-d28bde19f224	20
311385	loxapine succinate 25 MG Oral Capsule	PSN	509bad3c-b563-4042-b270-d28bde19f224	20
311386	loxapine succinate 5 MG Oral Capsule	PSN	509bad3c-b563-4042-b270-d28bde19f224	20
314075	loxapine succinate 50 MG Oral Capsule	PSN	509bad3c-b563-4042-b270-d28bde19f224	20
314078	loxapine 10 MG Oral Capsule	SCD	509bad3c-b563-4042-b270-d28bde19f224	20
311385	loxapine 25 MG Oral Capsule	SCD	509bad3c-b563-4042-b270-d28bde19f224	20
311386	loxapine 5 MG Oral Capsule	SCD	509bad3c-b563-4042-b270-d28bde19f224	20
314075	loxapine 50 MG Oral Capsule	SCD	509bad3c-b563-4042-b270-d28bde19f224	20
314078	loxapine 10 MG (as loxapine succinate 13.6 MG) Oral Capsule	SY	509bad3c-b563-4042-b270-d28bde19f224	20
311385	loxapine 25 MG (as loxapine succinate 34 MG) Oral Capsule	SY	509bad3c-b563-4042-b270-d28bde19f224	20
311386	loxapine 5 MG (as loxapine succinate 6.8 MG) Oral Capsule	SY	509bad3c-b563-4042-b270-d28bde19f224	20
314075	loxapine 50 MG (as loxapine succinate 68.1 MG) Oral Capsule	SY	509bad3c-b563-4042-b270-d28bde19f224	20
311385	loxapine succinate 25 MG Oral Capsule	PSN	832ce6b1-5846-4a5b-adb4-ac4e0f502d78	17
311385	loxapine 25 MG Oral Capsule	SCD	832ce6b1-5846-4a5b-adb4-ac4e0f502d78	17
311385	loxapine 25 MG (as loxapine succinate 34 MG) Oral Capsule	SY	832ce6b1-5846-4a5b-adb4-ac4e0f502d78	17
311385	loxapine succinate 25 MG Oral Capsule	PSN	2cf85ba7-7b62-6519-e063-6394a90a32c4	1
311385	loxapine 25 MG Oral Capsule	SCD	2cf85ba7-7b62-6519-e063-6394a90a32c4	1
311385	loxapine 25 MG (as loxapine succinate 34 MG) Oral Capsule	SY	2cf85ba7-7b62-6519-e063-6394a90a32c4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1396-01	00527139601	100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1396-01)	100 capsule	2011-09-26	0000-00-00	No	No	Current
0527-1396-10	00527139610	1000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1396-10)	1000 capsule	2011-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loxapine Capsules, USP	REMEDYREPACK INC.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	18
Loxapine Capsules, USP	Coupler LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	1
Loxapine Capsules, USP	Lannett Company, Inc.	2024-11-13	HUMAN PRESCRIPTION DRUG LABEL	20