Home NDC 16729-141 Clozapine
Product NDC 16729-141
11-digit product format 167290141
Labeler code 16729
Product ID 16729-141_40aa4dd3-36ca-1132-e063-6394a90a268d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clozapine
Dosage form TABLET
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA202873
Marketing category ANDA
Marketing start 2017-04-10
Substance CLOZAPINE
Active strength 25 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202873-001 CLOZAPINE CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 A202873-002 CLOZAPINE CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25
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 3 · 84 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 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202873-001 CLOZAPINE 25MG TABLET / ORAL AB 2015-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202873-002 CLOZAPINE 100MG TABLET / ORAL AB 2015-11-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 25 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197535 Internal RxNorm lookup 197536 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 16729-141-01 Clozapine 100 in 1 BOTTLE TABLET 100 16 16729-141-16 Clozapine 500 in 1 BOTTLE TABLET 500 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-141 CLOZAPINE TABLET [ACCORD HEALTHCARE INC.] 15 Current NDC, Legacy NDC, 2 package rows 20240718_25c0c6d5-f7b0-48e4-e054-00144ff8d46c.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 · 1 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 16729-141-01 16729014101 100 TABLET in 1 BOTTLE (16729-141-01) 100 tablet 2017-04-10 0000-00-00 No No Current 16729-141-16 16729014116 500 TABLET in 1 BOTTLE (16729-141-16) 500 tablet 2017-06-08 0000-00-00 No No Current