Home NDC 46708-199 Asenapine
Product NDC 46708-199
11-digit product format 467080199
Labeler code 46708
Product ID 46708-199_5b679b95-fdcb-43c5-a2fd-1e4eb9a13ba0
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 10 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 · 115 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 2026-11-14 07:37:17 2026-10 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206098-001 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206098-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206098-003 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2021-07-19 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 115 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Asenapine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASENAPINE 10 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 46708-199-10 Asenapine 10 in 1 BLISTER PACK TABLET 10 3 46708-199-31 Asenapine 100 in 1 CARTON TABLET 100 3 46708-199-31 Asenapine 10 in 1 BLISTER PACK TABLET 10 3 46708-199-60 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 46708-199 ASENAPINE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20230121_cf587c48-9cd2-4dc5-b0e9-21783c5633a6.zip
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 46708-199-10 46708019910 10 in 1 BLISTER PACK Historical 46708-199-31 46708019931 100 BLISTER PACK in 1 CARTON (46708-199-31) / 10 TABLET in 1 BLISTER PACK 100 blister pack 2021-07-20 0000-00-00 No No Current 46708-199-60 46708019960 60 BLISTER PACK in 1 CARTON (46708-199-60) / 10 TABLET in 1 BLISTER PACK (46708-199-10) 60 blister pack 2021-07-20 0000-00-00 No No Current