Home NDC 60687-415 Clozapine
Product NDC 60687-415
11-digit product format 606870415
Labeler code 60687
Product ID 60687-415_3de71656-5df7-240a-e063-6294a90a303a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clozapine
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA206433
Marketing category ANDA
Marketing start 2019-01-02
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 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 60687-415-01 Clozapine 100 in 1 BOX, UNIT-DOSE TABLET 100 7 60687-415-11 Clozapine 1 in 1 BLISTER PACK TABLET 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-415 CLOZAPINE TABLET [AMERICAN HEALTH PACKAGING] 6 Current NDC, Legacy NDC, 2 package rows 20241109_d36c298b-7292-46e0-898f-43d3e11c3cf4.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 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 ndc (product): 60687-415
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 60687-415-01 60687041501 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-415-01) / 1 TABLET in 1 BLISTER PACK (60687-415-11) 100 blister pack 2019-01-02 0000-00-00 No No Current 60687-415-11 60687041511 1 in 1 BLISTER PACK Historical