Clozapine

Product NDC: 59651-263
11-digit product format: 596510263
Labeler code: 59651
Product ID: 59651-263_5fe42ada-7ea2-4b77-bad5-93e1b1fb765d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clozapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA212923
Marketing category: ANDA
Marketing start: 2024-12-12
Substance: CLOZAPINE
Active strength: 150 mg/1
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212923-001	CLOZAPINE	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12
A212923-002	CLOZAPINE	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12
A212923-003	CLOZAPINE	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12
A212923-004	CLOZAPINE	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12
A212923-005	CLOZAPINE	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A212923-001	AB
A212923-002	AB
A212923-003	AB
A212923-004	AB
A212923-005	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.

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	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-001	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-002	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-003	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-004	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-005	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2024-12-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212923-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212923-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212923-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212923-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212923-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212923-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212923-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212923-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212923-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212923-005	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212923-005	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clozapine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOZAPINE	150 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
476177	Internal RxNorm lookup
476179	Internal RxNorm lookup
721773	Internal RxNorm lookup
996921	Internal RxNorm lookup
1006801	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
caf2d4a6-2a23-4992-a807-560c4204afc4	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	SPL version
59651-263-01	Clozapine	100 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	100	3
59651-263-48	Clozapine	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	3
59651-263-48	Clozapine	8 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	8	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-263-01	EA - Each	59651-263	a1160308-3571-4c40-8d89-404c19f13962	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-263	CLOZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]	2	Current NDC, 3 package rows	20250303_caf2d4a6-2a23-4992-a807-560c4204afc4.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clozapine	CLOZAPINE	Aurobindo Pharma Limited	caf2d4a6-2a23-4992-a807-560c4204afc4	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212923 application number: ANDA212923 ndc (product): 59651-263

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	caf2d4a6-2a23-4992-a807-560c4204afc4	3
721773	cloZAPine 12.5 MG Disintegrating Oral Tablet	PSN	caf2d4a6-2a23-4992-a807-560c4204afc4	3
1006801	cloZAPine 150 MG Disintegrating Oral Tablet	PSN	caf2d4a6-2a23-4992-a807-560c4204afc4	3
996921	cloZAPine 200 MG Disintegrating Oral Tablet	PSN	caf2d4a6-2a23-4992-a807-560c4204afc4	3
476179	cloZAPine 25 MG Disintegrating Oral Tablet	PSN	caf2d4a6-2a23-4992-a807-560c4204afc4	3
476177	clozapine 100 MG Disintegrating Oral Tablet	SCD	caf2d4a6-2a23-4992-a807-560c4204afc4	3
721773	clozapine 12.5 MG Disintegrating Oral Tablet	SCD	caf2d4a6-2a23-4992-a807-560c4204afc4	3
1006801	clozapine 150 MG Disintegrating Oral Tablet	SCD	caf2d4a6-2a23-4992-a807-560c4204afc4	3
996921	clozapine 200 MG Disintegrating Oral Tablet	SCD	caf2d4a6-2a23-4992-a807-560c4204afc4	3
476179	clozapine 25 MG Disintegrating Oral Tablet	SCD	caf2d4a6-2a23-4992-a807-560c4204afc4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59651-263-01	59651026301	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-263-01)		2024-12-12	No	No	Current
59651-263-48	59651026348	8 BLISTER PACK in 1 CARTON (59651-263-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	8 blister pack	2024-12-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clozapine	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-06-05	Human Prescription Drug Label	3