SECUADO

Product NDC: 68968-0173
11-digit product format: 689680173
Labeler code: 68968
Product ID: 68968-0173_ae8030f1-3ed5-40cf-a726-de4c14ee8c1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ASENAPINE
Dosage form: FILM, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Noven Therapeutics, LLC
Application: NDA212268
Marketing category: NDA
Marketing start: 2020-02-12
Substance: ASENAPINE
Active strength: 5.7 mg/d
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 9 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
2025-02-02 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	68968-0173-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68968-0173-3	`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	68968-0173-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68968-0173-3	`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	68968-0173-7	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68968-0173-3	`0efc9e666f02…`	`f202fb6c5f17…`

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	RLD / RS	Approval date
N212268-001	SECUADO	ASENAPINE	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11
N212268-002	SECUADO	ASENAPINE	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11
N212268-003	SECUADO	ASENAPINE	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212268-001	10022445	2033-07-25		Drug product	2019-10-18
N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27
N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13
N212268-001	11123305	2033-07-25		Drug product	2021-10-21
N212268-001	9687474	2033-07-25		Drug product	2019-10-18
N212268-001	11813364	2033-09-22		Drug product	2023-12-11
N212268-002	10022445	2033-07-25		Drug product	2019-10-18
N212268-002	10583121	2033-07-25	U-2763	Drug product	2020-03-27
N212268-002	10814002	2033-07-25	U-2763	Drug product	2020-11-13
N212268-002	11123305	2033-07-25		Drug product	2021-10-21
N212268-002	9687474	2033-07-25		Drug product	2019-10-18
N212268-002	11813364	2033-09-22		Drug product	2023-12-11
N212268-003	10022445	2033-07-25		Drug product	2019-10-18
N212268-003	10583121	2033-07-25	U-2763	Drug product	2020-03-27
N212268-003	10814002	2033-07-25	U-2763	Drug product	2020-11-13
N212268-003	11123305	2033-07-25		Drug product	2021-10-21
N212268-003	9687474	2033-07-25		Drug product	2019-10-18
N212268-003	11813364	2033-09-22		Drug product	2023-12-11

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 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 603 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212268-001	10022445	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	11123305	2033-07-25		Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	9687474	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	11813364	2033-09-22		Drug product	2023-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	10022445	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	11123305	2033-07-25		Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	9687474	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	11813364	2033-09-22		Drug product	2023-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	10022445	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	11123305	2033-07-25		Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	9687474	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	11813364	2033-09-22		Drug product	2023-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	10022445	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	11123305	2033-07-25		Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	9687474	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	11813364	2033-09-22		Drug product	2023-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	10022445	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	11123305	2033-07-25		Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	9687474	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	11813364	2033-09-22		Drug product	2023-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	10022445	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	11123305	2033-07-25		Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	9687474	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	11813364	2033-09-22		Drug product	2023-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212268-001	10022445	2033-07-25		Drug product	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-001	11123305	2033-07-25		Drug product	2021-10-21	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212268-001	NP	2022-10-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212268-002	NP	2022-10-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212268-003	NP	2022-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212268-001	NP	2022-10-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212268-002	NP	2022-10-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212268-003	NP	2022-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212268-001	NP	2022-10-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212268-002	NP	2022-10-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212268-003	NP	2022-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212268-001	NP	2022-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212268-002	NP	2022-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212268-003	NP	2022-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212268-001	NP	2022-10-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212268-002	NP	2022-10-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212268-003	NP	2022-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212268-001	NP	2022-10-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212268-002	NP	2022-10-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212268-003	NP	2022-10-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212268-001	NP	2022-10-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212268-002	NP	2022-10-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212268-003	NP	2022-10-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212268-001	NP	2022-10-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212268-002	NP	2022-10-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212268-003	NP	2022-10-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212268-001	NP	2022-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212268-002	NP	2022-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212268-003	NP	2022-10-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212268-001	NP	2022-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212268-002	NP	2022-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212268-003	NP	2022-10-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212268-001	NP	2022-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N212268-002	NP	2022-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N212268-003	NP	2022-10-11	`3f01610625f2…`
2023-01-26 05:58 UTC	2023-01	N212268-001	NP	2022-10-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N212268-002	NP	2022-10-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N212268-003	NP	2022-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212268-001	NP	2022-10-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212268-002	NP	2022-10-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212268-003	NP	2022-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212268-001	NP	2022-10-11	`f41ea6bd6efb…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASENAPINE	5.7 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JKZ19V908O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2261741	Internal RxNorm lookup
2261750	Internal RxNorm lookup
2261758	Internal RxNorm lookup
2265729	Internal RxNorm lookup
2265732	Internal RxNorm lookup
2265735	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
685eaf44-5944-4f38-afba-0a4fc0b3462b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
5230498f-5ba0-2e92-5ec3-564c02237e72	Product name	3	20210607
e1a56ed3-15d0-4970-9174-95c3bde43653	Product name	1	20200309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68968-0173-3	2025-02-01	C162847	48780-1	2cef2736-a476-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SECUADO ® (asenapine) transdermal system safely and effectively. See full prescribing information for SECUADO ® . SECUADO ® (asenapine) transdermal system Initial U.S. Approval: 2009
68968-0173-7	2025-02-01	C162847	48780-1	2cef2736-a476-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SECUADO ® (asenapine) transdermal system safely and effectively. See full prescribing information for SECUADO ® . SECUADO ® (asenapine) transdermal system Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68968-0173-3	SECUADO	1 d in 1 POUCH	FILM, EXTENDED RELEASE	1	13
68968-0173-3	SECUADO	30 in 1 CARTON	FILM, EXTENDED RELEASE	30	13
68968-0173-7	SECUADO	7 in 1 CARTON	FILM, EXTENDED RELEASE	7	13
68968-0173-7	SECUADO	1 d in 1 POUCH	FILM, EXTENDED RELEASE	1	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68968-0173-3	EA - Each	68968-0173	16183e06-8293-4f36-b950-ba9cc1c4d7cd	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68968-0173	SECUADO (ASENAPINE) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	13	Current NDC, Legacy NDC, 4 package rows	20250201_685eaf44-5944-4f38-afba-0a4fc0b3462b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SECUADO	ASENAPINE	Noven Therapeutics, LLC	685eaf44-5944-4f38-afba-0a4fc0b3462b	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212268 application number: NDA212268 ndc (product): 68968-0173

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JKZ19V908O	ASENAPINE	65576-45-6	ASENAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2261741	asenapine 3.8 MG/Day 24HR Transdermal System	PSN	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261750	asenapine 5.7 MG/Day 24HR Transdermal System	PSN	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261758	asenapine 7.6 MG/Day 24HR Transdermal System	PSN	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265729	SECUADO 3.8 MG/Day 24HR Transdermal System	PSN	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265732	SECUADO 5.7 MG/Day 24HR Transdermal System	PSN	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265735	SECUADO 7.6 MG/Day 24HR Transdermal System	PSN	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265729	24 HR asenapine 0.158 MG/HR Transdermal System [Secuado]	SBD	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265732	24 HR asenapine 0.238 MG/HR Transdermal System [Secuado]	SBD	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265735	24 HR asenapine 0.317 MG/HR Transdermal System [Secuado]	SBD	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261741	24 HR asenapine 0.158 MG/HR Transdermal System	SCD	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261750	24 HR asenapine 0.238 MG/HR Transdermal System	SCD	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261758	24 HR asenapine 0.317 MG/HR Transdermal System	SCD	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265729	24 HR Secuado 0.158 MG/HR Transdermal System	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265732	24 HR Secuado 0.238 MG/HR Transdermal System	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265735	24 HR Secuado 0.317 MG/HR Transdermal System	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261741	asenapine 3.8 MG/Day 24 HR Transdermal Patch	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261750	asenapine 5.7 MG/Day 24 HR Transdermal Patch	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2261758	asenapine 7.6 MG/Day 24 HR Transdermal Patch	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265729	Secuado 3.8 MG/Day 24 HR Transdermal System	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265732	Secuado 5.7 MG/Day 24 HR Transdermal System	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13
2265735	Secuado 7.6 MG/Day 24 HR Transdermal System	SY	685eaf44-5944-4f38-afba-0a4fc0b3462b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68968-0173-3	68968017303	30 POUCH in 1 CARTON (68968-0173-3) / 1 d in 1 POUCH	30 pouch	2020-02-12	0000-00-00	No	No	Current
68968-0173-7	68968017307	7 POUCH in 1 CARTON (68968-0173-7) / 1 d in 1 POUCH	7 pouch	2020-02-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SECUADO - Noven Therapeutics, LLC \| Hisamitsu Pharmaceutical Co. Inc.	Noven Therapeutics, LLC \| Hisamitsu Pharmaceutical Co. Inc.	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	13