Home NDC 46708-544 Asenapine
Product NDC 46708-544
11-digit product format 467080544
Labeler code 46708
Product ID 46708-544_b8b5c58b-40db-4b6f-b53d-f11a842bcf28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Asenapine
Dosage form TABLET
Route SUBLINGUAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA206098
Marketing category ANDA
Marketing start 2021-07-20
Substance ASENAPINE
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 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 A206098-001 ASENAPINE MALEATE ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 A206098-002 ASENAPINE MALEATE ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 A206098-003 ASENAPINE MALEATE ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19
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 · 103 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 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206098-002 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 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 103 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A206098-002 PC 2021-06-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206098-002 PC 2021-06-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206098-001 PC 2021-06-08 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A206098-002 PC 2021-06-08 5aa47cf7b7d7…
Additional Listing Data#
Finished product Yes
Brand name base Asenapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASENAPINE 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 JKZ19V908O 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 46708-544-10 Asenapine 10 in 1 BLISTER PACK TABLET 10 3 46708-544-31 Asenapine 10 in 1 BLISTER PACK TABLET 10 3 46708-544-31 Asenapine 100 in 1 CARTON TABLET 100 3 46708-544-60 Asenapine 60 in 1 CARTON TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-544 ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20230121_cf587c48-9cd2-4dc5-b0e9-21783c5633a6.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 46708-544-10 46708054410 10 in 1 BLISTER PACK Historical 46708-544-31 46708054431 100 BLISTER PACK in 1 CARTON (46708-544-31) / 10 TABLET in 1 BLISTER PACK 100 blister pack 2021-07-20 0000-00-00 No No Current 46708-544-60 46708054460 60 BLISTER PACK in 1 CARTON (46708-544-60) / 10 TABLET in 1 BLISTER PACK (46708-544-10) 60 blister pack 2021-07-20 0000-00-00 No No Current