Home NDC 0093-4405-05 Clozapine
Product NDC 0093-4405
Requested package NDC 0093-4405-05
11-digit product format 000934405
Labeler code 0093
Product ID 0093-4405_46cf5a5f-6610-4c5d-bac8-b9219fa9b699
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clozapine
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076809
Marketing category ANDA
Marketing start 2007-05-15
Marketing end 0000-00-00
Substance CLOZAPINE
Active strength 200 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076809-001 CLOZAPINE CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 A076809-002 CLOZAPINE CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 A076809-003 CLOZAPINE CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16
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 4 · 126 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 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076809-002 CLOZAPINE 100MG TABLET / ORAL AB 2005-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076809-003 CLOZAPINE 50MG TABLET / ORAL AB 2005-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076809-001 CLOZAPINE 200MG TABLET / ORAL AB 2005-12-16 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-4405-05 00093440505 500 TABLET in 1 BOTTLE (0093-4405-05) 500 tablet 2007-05-15 0000-00-00 No No Current