CLOZAPINE

Product NDC: 63629-2361
Requested package NDC: 63629-2361-1
11-digit product format: 636292361
Labeler code: 63629
Product ID: 63629-2361_41baa684-f0a3-4637-b6db-cf28aab76ba5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOZAPINE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075713
Marketing category: ANDA
Marketing start: 2005-08-19
Substance: CLOZAPINE
Active strength: 50 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-2361	63629-2361-1	D	Discontinued by firm		2026-08-17

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	Approval date
A075713-001	CLOZAPINE	CLOZAPINE	25MG	TABLET / ORAL	2002-11-15
A075713-002	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	2002-11-15
A075713-003	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	2005-08-19
A075713-004	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	2017-11-07

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075713-001	CLOZAPINE	25MG	TABLET / ORAL		2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075713-002	CLOZAPINE	100MG	TABLET / ORAL		2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075713-003	CLOZAPINE	50MG	TABLET / ORAL		2005-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075713-004	CLOZAPINE	200MG	TABLET / ORAL		2017-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075713-001	CLOZAPINE	25MG	TABLET / ORAL		2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075713-002	CLOZAPINE	100MG	TABLET / ORAL		2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075713-003	CLOZAPINE	50MG	TABLET / ORAL		2005-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075713-004	CLOZAPINE	200MG	TABLET / ORAL		2017-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075713-001	CLOZAPINE	25MG	TABLET / ORAL		2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075713-002	CLOZAPINE	100MG	TABLET / ORAL		2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075713-003	CLOZAPINE	50MG	TABLET / ORAL		2005-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075713-004	CLOZAPINE	200MG	TABLET / ORAL		2017-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075713-001	CLOZAPINE	25MG	TABLET / ORAL		2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075713-002	CLOZAPINE	100MG	TABLET / ORAL		2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075713-003	CLOZAPINE	50MG	TABLET / ORAL		2005-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075713-004	CLOZAPINE	200MG	TABLET / ORAL		2017-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2017-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2017-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2002-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2002-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2017-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2002-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2002-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2017-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2002-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2002-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2017-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2002-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-002	CLOZAPINE	100MG	TABLET / ORAL	AB	2002-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-003	CLOZAPINE	50MG	TABLET / ORAL	AB	2005-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2017-11-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075713-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075713-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075713-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075713-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075713-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075713-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075713-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075713-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075713-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075713-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075713-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075713-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075713-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075713-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075713-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075713-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075713-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075713-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075713-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075713-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075713-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075713-004	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fde12e54-43fa-cc16-3015-4c000a7b8d3e	Product name	5	20250812
0901063f-b37f-4bf1-8be6-1e2a469e57bc	Product name	2	20180209
e01fb60f-a608-2c68-dfdd-23e6433ece68	Product name	5	20180209
7a7f58c4-be43-7e82-4dfc-128bbed4230a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2361-1	CLOZAPINE	100 in 1 BOTTLE	TABLET	100		106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2361-1	EA - Each	63629-2361	8f130bfe-6cf2-4f9e-9529-c38f42922521	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2361	CLOZAPINE TABLET [BRYANT RANCH PREPACK]	106	Current NDC, Legacy NDC, 1 package rows	20240602_9b035a6a-f5c1-43a8-9203-cc016dc6e422.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J60AR2IKIC	CLOZAPINE	5786-21-0	CLOZAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
429212	cloZAPine 50 MG Oral Tablet	PSN	9b035a6a-f5c1-43a8-9203-cc016dc6e422	106
429212	clozapine 50 MG Oral Tablet	SCD	9b035a6a-f5c1-43a8-9203-cc016dc6e422	106

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2361-1	63629236101	100 TABLET in 1 BOTTLE (63629-2361-1)	100 tablet	2005-08-19	0000-00-00	No	No	Current