CLOZAPINE

Product NDC: 57664-347
11-digit product format: 576640347
Labeler code: 57664
Product ID: 57664-347_5dab493f-f2b8-4841-9332-1d9d97451460
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOZAPINE
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA075713
Marketing category: ANDA
Marketing start: 2002-11-15
Marketing end: 0000-00-00
Substance: CLOZAPINE
Active strength: 100 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-347		D	Discontinued by firm	2026-10-16
excluded package	package	57664-347	57664-347-13	D	Discontinued by firm	2026-10-16
excluded package	package	57664-347	57664-347-88	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-347-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-347-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-347-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-347-88	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A075713-001	CLOZAPINE	25MG	TABLET / ORAL		2002-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075713-002	CLOZAPINE	100MG	TABLET / ORAL		2002-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075713-003	CLOZAPINE	50MG	TABLET / ORAL		2005-08-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075713-004	CLOZAPINE	200MG	TABLET / ORAL		2017-11-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075713-001	CLOZAPINE	25MG	TABLET / ORAL		2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075713-002	CLOZAPINE	100MG	TABLET / ORAL		2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075713-003	CLOZAPINE	50MG	TABLET / ORAL		2005-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075713-004	CLOZAPINE	200MG	TABLET / ORAL		2017-11-07	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A075713-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075713-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075713-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075713-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075713-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075713-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075713-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075713-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075713-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075713-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075713-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075713-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075713-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075713-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075713-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075713-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075713-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075713-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075713-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075713-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075713-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075713-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075713-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075713-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075713-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075713-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075713-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075713-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075713-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075713-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075713-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075713-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075713-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075713-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075713-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075713-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075713-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075713-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075713-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075713-004	AB	1	`a67488948f0b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-347-13	EA - Each	57664-347	32cae948-9a7a-4c8e-bfce-9a8c1237b816	1	2012-07-24
57664-347-88	EA - Each	57664-347	892d4a57-af36-489b-9eaa-a5bc4974da4c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOZAPINE	ACTIVE INGREDIENT	J60AR2IKIC	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
CLOZAPINE	ACTIVE MOIETY	J60AR2IKIC	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLOZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14

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	Marketing end	Sample	Exclude flag	Status
57664-347-13	57664034713	500 TABLET in 1 BOTTLE (57664-347-13)	500 tablet	2002-11-15	0000-00-00	No	No	Current
57664-347-88	57664034788	100 TABLET in 1 BOTTLE (57664-347-88)	100 tablet	2002-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOZAPINE	Bryant Ranch Prepack	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	105
CLOZAPINE	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	25
CLOZAPINE	Bryant Ranch Prepack	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	100
CLOZAPINE	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	104