Home NDC 59762-2012 Asenapine
Product NDC 59762-2012
11-digit product format 597622012
Labeler code 59762
Product ID 59762-2012_fb1d5c85-98bc-4d28-a7f4-6c363269042e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name asenapine maleate
Dosage form TABLET
Route SUBLINGUAL
Labeler Greenstone LLC
Application NDA022117
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-05-01
Marketing end 0000-00-00
Substance ASENAPINE MALEATE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-2012 ASENAPINE (ASENAPINE MALEATE) TABLET [GREENSTONE LLC] 3 Legacy NDC 20231019_86a40942-8d6b-478c-995f-3c346b197463.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-2012-6 59762201206 6 BLISTER PACK in 1 BOX (59762-2012-6) > 10 TABLET in 1 BLISTER PACK 6 blister pack 2020-05-01 0000-00-00 No No Current