Home NDC 0456-2402 SAPHRIS
Product NDC 0456-2402
11-digit product format 004562402
Labeler code 0456
Product ID 0456-2402_9827c4dd-ffac-4022-a021-d1b15a364ecd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Asenapine Maleate
Dosage form TABLET
Route SUBLINGUAL
Labeler Allergan, Inc.
Application NDA022117
Marketing category NDA
Marketing start 2014-12-30
Substance ASENAPINE MALEATE
Active strength 2.5 mg/1
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 0456-2402 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 0456-2402 0456-2402-99 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…
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 RLD / RS Approval date N022117-001 SAPHRIS ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 N022117-002 SAPHRIS ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 N022117-003 SAPHRIS ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 21 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022117-001 7741358 2026-04-06 U-1064 Drug substance, Drug product 2017-02-10 N022117-001 7741358 2026-04-06 U-1960 Drug substance, Drug product 2017-02-10 N022117-001 7741358 2026-04-06 U-1961 Drug substance, Drug product 2017-02-10 N022117-001 7741358 2026-04-06 U-1962 Drug substance, Drug product 2017-02-10 N022117-001 7741358 2026-04-06 U-1963 Drug substance, Drug product 2017-02-10 N022117-001 8022228 2026-04-06 Drug substance, Drug product 2014-07-29 N022117-001 7741358*PED 2026-10-06 Pediatric extension N022117-001 8022228*PED 2026-10-06 Pediatric extension N022117-002 7741358 2026-04-06 U-1064 Drug substance, Drug product 2017-02-10 N022117-002 7741358 2026-04-06 U-1960 Drug substance, Drug product 2017-02-10 N022117-002 7741358 2026-04-06 U-1961 Drug substance, Drug product 2017-02-10 N022117-002 7741358 2026-04-06 U-1962 Drug substance, Drug product 2017-02-10 N022117-002 7741358 2026-04-06 U-1963 Drug substance, Drug product 2017-02-10 N022117-002 8022228 2026-04-06 Drug substance, Drug product 2014-07-29 N022117-002 7741358*PED 2026-10-06 Pediatric extension N022117-002 8022228*PED 2026-10-06 Pediatric extension N022117-003 7741358 2026-04-06 U-1893 Drug substance, Drug product 2016-09-12 N022117-003 7741358 2026-04-06 U-1966 Drug substance, Drug product 2016-09-12 N022117-003 8022228 2026-04-06 Drug substance, Drug product 2016-09-12 N022117-003 7741358*PED 2026-10-06 Pediatric extension N022117-003 8022228*PED 2026-10-06 Pediatric extension
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 4 · 123 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 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022117-002 SAPHRIS EQ 10MG BASE TABLET / SUBLINGUAL AB RLD, RS 2009-08-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022117-003 SAPHRIS EQ 2.5MG BASE TABLET / SUBLINGUAL AB RLD 2015-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022117-001 SAPHRIS EQ 5MG BASE TABLET / SUBLINGUAL AB RLD 2009-08-13 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 observed states.
Observed Orange Book patent history# Patent history page 1 of 24 · 951 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 N022117-001 7741358 2026-04-06 U-1960 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 7741358 2026-04-06 U-1064 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 7741358 2026-04-06 U-1961 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 7741358 2026-04-06 U-1962 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 7741358 2026-04-06 U-1963 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 8022228 2026-04-06 Drug substance, Drug product 2014-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 7741358*PED 2026-10-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-001 8022228*PED 2026-10-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 7741358 2026-04-06 U-1963 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 7741358 2026-04-06 U-1064 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 7741358 2026-04-06 U-1961 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 7741358 2026-04-06 U-1960 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 7741358 2026-04-06 U-1962 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 8022228 2026-04-06 Drug substance, Drug product 2014-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 7741358*PED 2026-10-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-002 8022228*PED 2026-10-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-003 7741358 2026-04-06 U-1966 Drug substance, Drug product 2016-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-003 7741358 2026-04-06 U-1893 Drug substance, Drug product 2016-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-003 8022228 2026-04-06 Drug substance, Drug product 2016-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-003 7741358*PED 2026-10-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022117-003 8022228*PED 2026-10-06 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 7741358 2026-04-06 U-1960 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 7741358 2026-04-06 U-1064 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 7741358 2026-04-06 U-1961 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 7741358 2026-04-06 U-1962 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 7741358 2026-04-06 U-1963 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 8022228 2026-04-06 Drug substance, Drug product 2014-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 7741358*PED 2026-10-06 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-001 8022228*PED 2026-10-06 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 7741358 2026-04-06 U-1963 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 7741358 2026-04-06 U-1064 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 7741358 2026-04-06 U-1961 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 7741358 2026-04-06 U-1960 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 7741358 2026-04-06 U-1962 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 8022228 2026-04-06 Drug substance, Drug product 2014-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 7741358*PED 2026-10-06 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-002 8022228*PED 2026-10-06 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-003 7741358 2026-04-06 U-1966 Drug substance, Drug product 2016-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-003 7741358 2026-04-06 U-1893 Drug substance, Drug product 2016-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022117-003 8022228 2026-04-06 Drug substance, Drug product 2016-09-12 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base SAPHRIS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASENAPINE MALEATE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CU9463U2E2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859975 Internal RxNorm lookup 859979 Internal RxNorm lookup 859981 Internal RxNorm lookup 859983 Internal RxNorm lookup 1606337 Internal RxNorm lookup 1606490 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0456-2402 SAPHRIS (ASENAPINE MALEATE) TABLET [ALLERGAN, INC.] 21 Current NDC, Legacy NDC, 7 package rows 20250212_5429f134-839f-4ffc-9944-55f51238def8.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 SAPHRIS ASENAPINE MALEATE Allergan, Inc. 5429f134-839f-4ffc-9944-55f51238def8 2025-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022117 application number: NDA022117 ndc (product): 0456-2402
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0456-2402-06 00456240206 10 in 1 BLISTER PACK Historical 0456-2402-10 00456240210 1 CASE in 1 CARTON (0456-2402-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK 1 case 2014-12-30 0000-00-00 Yes No Current 0456-2402-11 00456240211 10 in 1 BLISTER PACK Historical 0456-2402-60 00456240260 6 CASE in 1 CARTON (0456-2402-60) / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACK 6 case 2014-12-30 0000-00-00 No No Current 0456-2402-63 00456240263 10 BLISTER PACK in 1 CARTON (0456-2402-63) / 10 TABLET in 1 BLISTER PACK (0456-2402-11) 10 blister pack 2014-12-30 0000-00-00 No No Current