Home NDC 69809-0127 Clozaril
Product NDC 69809-0127
11-digit product format 698090127
Labeler code 69809
Product ID 69809-0127_14601465-eda2-4063-b606-cb6cfcaaca3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clozapine
Dosage form TABLET
Route ORAL
Labeler HLS Therapeutics (USA), Inc.
Application NDA019758
Marketing category NDA
Marketing start 2016-05-06
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 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RS 1989-09-26 N019758-003 CLOZARIL CLOZAPINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 N019758-004 CLOZARIL CLOZAPINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20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N019758-003 CLOZARIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-004 CLOZARIL 200MG **Federal Register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.
Additional Listing Data#
Finished product Yes
Brand name base Clozaril
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 104775 Internal RxNorm lookup 104776 Internal RxNorm lookup 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69809-0127-5 Clozaril 100 in 1 BOTTLE TABLET 100 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69809-0127 CLOZARIL (CLOZAPINE) TABLET [HLS THERAPEUTICS (USA), INC.] 19 Current NDC, Legacy NDC, 1 package rows 20250327_90876802-0e3a-44c9-9ff7-1754dfbe736a.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 69809-0127-5 69809012705 100 TABLET in 1 BOTTLE (69809-0127-5) 100 tablet 2016-05-06 0000-00-00 No No Current