Home NDC 0378-0972 Clozapine
Product NDC 0378-0972
11-digit product format 003780972
Labeler code 0378
Product ID 0378-0972_a8cef9ad-4bf9-4289-9473-400c8f1a95ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clozapine
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA075417
Marketing category ANDA
Marketing start 2010-04-20
Substance CLOZAPINE
Active strength 50 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075417-001 CLOZAPINE CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 A075417-002 CLOZAPINE CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 A075417-003 CLOZAPINE CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 A075417-004 CLOZAPINE CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 A075417-005 CLOZAPINE CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15
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 6 · 210 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 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075417-001 CLOZAPINE 25MG TABLET / ORAL AB 1999-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075417-002 CLOZAPINE 100MG TABLET / ORAL AB 1999-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075417-003 CLOZAPINE 12.5MG TABLET / ORAL 2010-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075417-004 CLOZAPINE 50MG TABLET / ORAL AB 2010-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075417-005 CLOZAPINE 200MG TABLET / ORAL AB 2010-04-15 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clozapine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOZAPINE 50 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 0378-0972-01 Clozapine 100 in 1 BOTTLE, PLASTIC TABLET 100 35 0378-0972-02 Clozapine 100 in 1 BOTTLE, PLASTIC TABLET 100 35
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0972 CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.] 32 Current NDC, Legacy NDC, 2 package rows 20250417_883b5d43-0339-7dc1-f775-93791fb9b978.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 · 3 matching rows.
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 0378-0972-01 00378097201 100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-01) 100 tablet 2010-04-20 0000-00-00 No No Current 0378-0972-02 00378097202 100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-02) 100 tablet 2020-10-01 0000-00-00 No No Current