CLOZAPINE

Product NDC: 72603-912
Requested package NDC: 72603-912-01
11-digit product format: 726030912
Labeler code: 72603
Product ID: 72603-912_61fe53d5-ed5c-4e45-9189-709d08d386cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOZAPINE
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA206433
Marketing category: ANDA
Marketing start: 2026-08-01
Substance: CLOZAPINE
Active strength: 50 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
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
A206433-001	CLOZAPINE	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29
A206433-002	CLOZAPINE	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29
A206433-003	CLOZAPINE	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29
A206433-004	CLOZAPINE	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206433-001	AB
A206433-002	AB
A206433-003	AB
A206433-004	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 5 · 164 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	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206433-001	CLOZAPINE	25MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-002	CLOZAPINE	50MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-003	CLOZAPINE	100MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-004	CLOZAPINE	200MG	TABLET / ORAL	AB	2016-11-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A206433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206433-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206433-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206433-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206433-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206433-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206433-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206433-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206433-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206433-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206433-004	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	50 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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
61fe53d5-ed5c-4e45-9189-709d08d386cb	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOZAPINE	CLOZAPINE	Cardinal Health 107, LLC	7c748f8a-73ce-4bd3-aa30-9c66657f06ec	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433
CLOZAPINE	CLOZAPINE	Major Pharmaceuticals	9db7aefb-f607-4158-a310-181e631bc648	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433
CLOZAPINE	CLOZAPINE	Aurobindo Pharma Limited	5021d643-32d2-4167-b5d8-90870e68a787	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433
Clozapine	CLOZAPINE	American Health Packaging	d36c298b-7292-46e0-898f-43d3e11c3cf4	2025-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206433 application number: ANDA206433

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
72603-912-01	72603091201	100 TABLET in 1 BOTTLE (72603-912-01)	100 tablet	2026-08-01	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOZAPINE	NorthStar Rx LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-05-11	Human Prescription Drug Label	1