Clozapine

Product NDC: 48433-022
Requested package NDC: 48433-022-04
11-digit product format: 484330022
Labeler code: 48433
Product ID: 48433-022_4cedfa23-a6bd-ddf7-e063-6294a90aa994
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clozapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA201824
Marketing category: ANDA
Marketing start: 2026-03-05
Substance: CLOZAPINE
Active strength: 100 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 1.

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	Approval date
A201824-002	CLOZAPINE	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15
A201824-003	CLOZAPINE	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15
A201824-004	CLOZAPINE	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07
A201824-005	CLOZAPINE	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201824-002	AB
A201824-003	AB
A201824-004	AB
A201824-005	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 4 · 122 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
2026-02-19 14:30 UTC	2026-02	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201824-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201824-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201824-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201824-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2023-08-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201824-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201824-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201824-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201824-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201824-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201824-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201824-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201824-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201824-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201824-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201824-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201824-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201824-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201824-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201824-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201824-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201824-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201824-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201824-005	AB	1	`d06236e962d9…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
476177	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
09231d80-6343-4a34-bd5b-100c547fd3c9	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-022-01	Clozapine	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	1		2
48433-022-04	Clozapine	40 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	40		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
48433-022-04	EA - Each	48433-022	8ff38b7d-79aa-49c6-83e6-3251a77f48b5	1	2026-05-22

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	Safecor Health, LLC	09231d80-6343-4a34-bd5b-100c547fd3c9	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201824 application number: ANDA201824 ndc (package): 48433-022-04 ndc (product): 48433-022 ndc11 (package): 48433002204
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219	2025-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201824 application number: ANDA201824
Clozapine	CLOZAPINE	Mylan Institutional Inc.	976be6e3-a9db-49c6-9b02-1ab168cf17b1	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201824 application number: ANDA201824

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
476177	cloZAPine 100 MG Disintegrating Oral Tablet	PSN	09231d80-6343-4a34-bd5b-100c547fd3c9	2
476177	clozapine 100 MG Disintegrating Oral Tablet	SCD	09231d80-6343-4a34-bd5b-100c547fd3c9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-022-04	48433002204	40 BLISTER PACK in 1 CARTON (48433-022-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (48433-022-01)	40 blister pack	2026-03-05	No	No	Current