Home NDC 64330-625 Asenapine Maleate
Product NDC 64330-625
11-digit product format 643300625
Labeler code 64330
Product ID 64330-625_055ddb13-3143-49f8-a771-06c7bea5a30a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Asenapine Maleate
Dosage form TABLET
Route SUBLINGUAL
Labeler Centaur Pharmaceuticals Private Limited
Application ANDA205960
Marketing category ANDA
Marketing start 2020-12-10
Marketing end 0000-00-00
Substance ASENAPINE MALEATE
Active strength 3 1/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64330-625-01 64330062501 60 TABLET in 1 BOX (64330-625-01) 60 tablet 2020-12-10 0000-00-00 No No Current