Home NDC 18860-121 VERSACLOZ
Product NDC 18860-121
11-digit product format 188600121
Labeler code 18860
Product ID 18860-121_f7d4b279-d9de-4fb3-b67c-24e2b4d39b50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clozapine
Dosage form SUSPENSION
Route ORAL
Labeler Jazz Pharmaceuticals, Inc.
Application NDA203479
Marketing category NDA
Marketing start 2013-02-15
Marketing end 2019-05-31
Substance CLOZAPINE
Active strength 50 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 18860-121-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 18860-121-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 18860-121-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 18860-121-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 18860-121-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 18860-121-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 18860-121-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 18860-121-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 18860-121-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 18860-121-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 18860-121-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 18860-121-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203479-001 VERSACLOZ CLOZAPINE 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203479-001 8057811 2028-05-01 Drug product 2019-11-15
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 2 · 42 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 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 e64feba35796…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 a50c72e98297…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VERSACLOZ CLOZAPINE TruPharma LLC 2592c9a8-fd74-4e0d-a895-b07b014cf355 2025-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203479 application number: NDA203479