Clozapine

Product NDC: 48433-025
Requested package NDC: 48433-025-20
11-digit product format: 484330025
Labeler code: 48433
Product ID: 48433-025_4c992fd8-c815-bfb3-e063-6294a90a8e6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clozapine
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA075417
Marketing category: ANDA
Marketing start: 2026-02-23
Substance: CLOZAPINE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075417-001	CLOZAPINE	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27
A075417-002	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27
A075417-003	CLOZAPINE	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15
A075417-004	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15
A075417-005	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075417-001	AB
A075417-002	AB
A075417-004	AB
A075417-005	AB

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 6 · 215 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
2026-09-14 22:38:34	2026-08	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-001	CLOZAPINE	25MG	TABLET / ORAL	AB	1999-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-002	CLOZAPINE	100MG	TABLET / ORAL	AB	1999-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-003	CLOZAPINE	12.5MG	TABLET / ORAL		2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-004	CLOZAPINE	50MG	TABLET / ORAL	AB	2010-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-005	CLOZAPINE	200MG	TABLET / ORAL	AB	2010-04-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075417-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075417-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075417-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075417-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075417-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075417-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075417-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075417-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075417-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075417-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075417-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075417-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075417-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075417-005	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Clozapine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOZAPINE	200 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197535	Internal RxNorm lookup
197536	Internal RxNorm lookup
309374	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0fa59238-f0a6-4d00-9d8d-df2a43718fc1	Available on FDA.report

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
48433-025-01	Clozapine	1 in 1 BLISTER PACK	TABLET	1		2
48433-025-20	Clozapine	100 in 1 CARTON	TABLET	100		2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	883b5d43-0339-7dc1-f775-93791fb9b978	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075417 application number: ANDA075417
Clozapine	CLOZAPINE	Safecor Health LLC	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075417 application number: ANDA075417 ndc (package): 48433-025-20 ndc (product): 48433-025 ndc11 (package): 48433002520
Clozapine	CLOZAPINE	Mylan Institutional Inc.	d5c8a456-6f3c-4963-b321-4ed746f690e4	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075417 application number: ANDA075417

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
197535	cloZAPine 100 MG Oral Tablet	PSN	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2
309374	cloZAPine 200 MG Oral Tablet	PSN	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2
197536	cloZAPine 25 MG Oral Tablet	PSN	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2
197535	clozapine 100 MG Oral Tablet	SCD	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2
309374	clozapine 200 MG Oral Tablet	SCD	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2
197536	clozapine 25 MG Oral Tablet	SCD	0fa59238-f0a6-4d00-9d8d-df2a43718fc1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-025-20	48433002520	100 BLISTER PACK in 1 CARTON (48433-025-20) / 1 TABLET in 1 BLISTER PACK (48433-025-01)	100 blister pack	2026-02-23	No	No	Current