Home NDC 52817-601 VERSACLOZ
Product NDC 52817-601
11-digit product format 528170601
Labeler code 52817
Product ID 52817-601_38837e2a-084f-4179-e063-6394a90afd45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clozapine
Dosage form SUSPENSION
Route ORAL
Labeler TruPharma LLC
Application NDA203479
Marketing category NDA
Marketing start 2018-06-15
Substance CLOZAPINE
Active strength 50 mg/mL
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 · 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…
Additional Listing Data#
Finished product Yes
Brand name base VERSACLOZ
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOZAPINE 50 mg/mL
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 1369825 Internal RxNorm lookup 1369831 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 52817-601-38 VERSACLOZ 100 mL in 1 BOTTLE SUSPENSION 100 6 52817-601-38 VERSACLOZ 1 in 1 BOX SUSPENSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-601 VERSACLOZ (CLOZAPINE) SUSPENSION [TRUPHARMA LLC] 5 Current NDC, Legacy NDC, 2 package rows 20250207_2592c9a8-fd74-4e0d-a895-b07b014cf355.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 52817-601-38 52817060138 1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLE 1 bottle 2018-06-15 0000-00-00 No No Current