Home NDC 51991-359 Asenapine
Product NDC 51991-359
11-digit product format 519910359
Labeler code 51991
Product ID 51991-359_194b5ce2-7d21-4617-9888-9a97b9d7690a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ASENAPINE MALEATE
Dosage form TABLET
Route SUBLINGUAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA205960
Marketing category ANDA
Marketing start 2021-03-08
Substance ASENAPINE MALEATE
Active strength 5 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 44 .
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 · 113 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 2026-10-15 13:18:30 2026-09 A205960-001 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205960-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205960-003 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2021-03-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205960-001 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205960-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205960-003 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2021-03-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205960-001 ASENAPINE MALEATE EQ 2.5MG BASE TABLET / SUBLINGUAL AB 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205960-002 ASENAPINE MALEATE EQ 10MG BASE TABLET / SUBLINGUAL AB 2020-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205960-003 ASENAPINE MALEATE EQ 5MG BASE TABLET / SUBLINGUAL AB 2021-03-08 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 113 observed states.
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 MALEATE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51991-359-11 Asenapine 10 in 1 BOX TABLET 10 5 51991-359-60 Asenapine 10 in 1 BLISTER PACK TABLET 10 5 51991-359-60 Asenapine 6 in 1 BOX TABLET 6 5 51991-359-99 Asenapine 10 in 1 BLISTER PACK TABLET 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-359 ASENAPINE (ASENAPINE MALEATE) TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240327_f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e.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 Asenapine ASENAPINE MALEATE MSN LABORATORIES PRIVATE LIMITED 4c7a1b17-e73e-4417-a172-bfb03569d7ff 2021-08-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205960 application number: ANDA205960
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 51991-359-11 51991035911 10 BLISTER PACK in 1 BOX (51991-359-11) / 10 TABLET in 1 BLISTER PACK (51991-359-99) 10 blister pack 2021-03-08 0000-00-00 No No Current 51991-359-60 51991035960 6 BLISTER PACK in 1 BOX (51991-359-60) / 10 TABLET in 1 BLISTER PACK 6 blister pack 2021-03-08 0000-00-00 No No Current 51991-359-99 51991035999 10 in 1 BLISTER PACK Historical