Home NDC 69539-058 Asenapine
Product NDC 69539-058
11-digit product format 695390058
Labeler code 69539
Product ID 69539-058_0c0d566e-5315-4e29-a207-5f2eb75910f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ASENAPINE MALEATE
Dosage form TABLET
Route SUBLINGUAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA205960
Marketing category ANDA
Marketing start 2021-08-27
Substance ASENAPINE MALEATE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS 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.
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 RLD / RS 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.
Additional Listing Data#
Finished product Yes
Brand name base Asenapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASENAPINE MALEATE 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859975 Internal RxNorm lookup 859981 Internal RxNorm lookup 1606337 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69539-058-34 Asenapine 60 in 1 BOX TABLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-058 ASENAPINE (ASENAPINE MALEATE) TABLET [MSN LABORATORIES PRIVATE LIMITED] 7 Current NDC, Legacy NDC, 1 package rows 20210902_4c7a1b17-e73e-4417-a172-bfb03569d7ff.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 · 2 matching rows.
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 69539-058-34 69539005834 60 TABLET in 1 BOX (69539-058-34) 60 tablet 2021-08-27 0000-00-00 No No Current