Asenapine Maleate

Product NDC: 64330-625
11-digit product format: 643300625
Labeler code: 64330
Product ID: 64330-625_055ddb13-3143-49f8-a771-06c7bea5a30a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Asenapine Maleate
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Centaur Pharmaceuticals Private Limited
Application: ANDA205960
Marketing category: ANDA
Marketing start: 2020-12-10
Marketing end: 0000-00-00
Substance: ASENAPINE MALEATE
Active strength: 3 1/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205960-001	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10
A205960-002	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10
A205960-003	ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205960-001	AB
A205960-002	AB
A205960-003	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 3 · 104 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	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-002	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-003	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	2021-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205960-001	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	2020-12-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 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	A205960-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205960-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205960-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205960-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205960-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205960-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205960-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205960-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205960-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205960-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205960-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205960-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205960-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205960-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205960-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205960-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205960-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Asenapine	ASENAPINE MALEATE	Breckenridge Pharmaceutical, Inc.	f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e	2024-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205960 application number: ANDA205960
Asenapine	ASENAPINE MALEATE	MSN LABORATORIES PRIVATE LIMITED	4c7a1b17-e73e-4417-a172-bfb03569d7ff	2021-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205960 application number: ANDA205960

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CU9463U2E2	ASENAPINE MALEATE	85650-56-2	ASENAPINE MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64330-625-01	64330062501	60 TABLET in 1 BOX (64330-625-01)	60 tablet	2020-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Asenapine Maleate	Centaur Pharmaceuticals Private Limited	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	2