Home NDC 0781-5989-01 Clozapine
Product NDC 0781-5989
Requested package NDC 0781-5989-01
11-digit product format 007815989
Labeler code 0781
Product ID 0781-5989_9da402bb-c2b6-4db2-af7c-90e5c3d6f35c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clozapine
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc.
Application NDA019758
Marketing category NDA
Marketing start 2016-05-06
Marketing end 2021-06-30
Substance CLOZAPINE
Active strength 25 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019758-001 CLOZARIL CLOZAPINE 25MG TABLET / ORAL AB RLD 1989-09-26 N019758-002 CLOZARIL CLOZAPINE 100MG TABLET / ORAL AB RLD, RS 1989-09-26 N019758-003 CLOZARIL CLOZAPINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 N019758-004 CLOZARIL CLOZAPINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 168 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 2026-08-18 06:07:40 2026-07 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-003 CLOZARIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-004 CLOZARIL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019758-003 CLOZARIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019758-004 CLOZARIL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 observed states.
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 Clozaril CLOZAPINE HLS Therapeutics (USA), Inc. 90876802-0e3a-44c9-9ff7-1754dfbe736a 2025-06-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019758 application number: NDA019758
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-5989-01 00781598901 100 TABLET in 1 BOTTLE (0781-5989-01) 100 tablet 2016-05-06 2021-06-30 No No Current