Home NDC 65862-846 CLOZAPINE
Product NDC 65862-846
11-digit product format 658620846
Labeler code 65862
Product ID 65862-846_a46da176-2ed3-4b9a-b06f-efab2936a5ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLOZAPINE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA206433
Marketing category ANDA
Marketing start 2016-11-29
Substance CLOZAPINE
Active strength 100 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-846 UNFINISHED Active or certified unfinished drug listing 2026-08-07 unfinished package package 65862-846 65862-846-39 UNFINISHED Active or certified unfinished drug listing 2026-08-07
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-846-39 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-846-39 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-846-39 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-846-39 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-846-39 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-846-39 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-846-39 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-846-39 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-846-39 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-846-39 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-846-39 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-846-39 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-846-39 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-846-39 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206433-001 CLOZAPINE CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 A206433-002 CLOZAPINE CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 A206433-003 CLOZAPINE CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 A206433-004 CLOZAPINE CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206433-001 CLOZAPINE 25MG TABLET / ORAL AB 2016-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206433-002 CLOZAPINE 50MG TABLET / ORAL AB 2016-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206433-003 CLOZAPINE 100MG TABLET / ORAL AB 2016-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206433-004 CLOZAPINE 200MG TABLET / ORAL AB 2016-11-29 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CLOZAPINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOZAPINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J60AR2IKIC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197535 Internal RxNorm lookup 197536 Internal RxNorm lookup 309374 Internal RxNorm lookup 429212 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 65862-846-01 CLOZAPINE 100 in 1 BOTTLE TABLET 100 15 65862-846-05 CLOZAPINE 500 in 1 BOTTLE TABLET 500 15 65862-846-10 CLOZAPINE 10 in 1 BLISTER PACK TABLET 10 15 65862-846-78 CLOZAPINE 10 in 1 CARTON TABLET 10 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-846 CLOZAPINE TABLET [AUROBINDO PHARMA LIMITED] 13 Current NDC, Legacy NDC, 4 package rows 20250306_5021d643-32d2-4167-b5d8-90870e68a787.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLOZAPINE CLOZAPINE Cardinal Health 107, LLC 7c748f8a-73ce-4bd3-aa30-9c66657f06ec 2026-04-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206433 application number: ANDA206433 CLOZAPINE CLOZAPINE Major Pharmaceuticals 9db7aefb-f607-4158-a310-181e631bc648 2026-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206433 application number: ANDA206433 CLOZAPINE CLOZAPINE Aurobindo Pharma Limited 5021d643-32d2-4167-b5d8-90870e68a787 2025-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206433 application number: ANDA206433 ndc (product): 65862-846 Clozapine CLOZAPINE American Health Packaging d36c298b-7292-46e0-898f-43d3e11c3cf4 2025-09-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206433 application number: ANDA206433
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 65862-846-01 65862084601 100 TABLET in 1 BOTTLE (65862-846-01) 100 tablet 2016-11-29 0000-00-00 No No Current 65862-846-05 65862084605 500 TABLET in 1 BOTTLE (65862-846-05) 500 tablet 2016-11-29 0000-00-00 No No Current 65862-846-10 65862084610 10 in 1 BLISTER PACK Historical 65862-846-39 65862084639 3000 TABLET in 1 BAG (65862-846-39) 3000 tablet 10-JAN-24 Current 65862-846-78 65862084678 10 BLISTER PACK in 1 CARTON (65862-846-78) / 10 TABLET in 1 BLISTER PACK (65862-846-10) 10 blister pack 2016-11-29 0000-00-00 No No Current