Clozapine

Product NDC: 0093-3087
Requested package NDC: 0093-3087-01
11-digit product format: 000933087
Labeler code: 0093
Product ID: 0093-3087_71779a58-9f75-4af4-bfdd-4ea77d1a8e3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clozapine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Teva Pharmaceuticals USA Inc
Application: NDA021590
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-05-05
Marketing end: 2022-08-31
Substance: CLOZAPINE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0093-3087	0093-3087-01	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021590-001	FAZACLO ODT	CLOZAPINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10
N021590-002	FAZACLO ODT	CLOZAPINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10
N021590-003	FAZACLO ODT	CLOZAPINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03
N021590-004	FAZACLO ODT	CLOZAPINE	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30
N021590-005	FAZACLO ODT	CLOZAPINE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09
N021590-006	FAZACLO ODT	CLOZAPINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09

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 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2005-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-005	FAZACLO ODT	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021590-006	FAZACLO ODT	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2010-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021590-001	FAZACLO ODT	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021590-002	FAZACLO ODT	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021590-003	FAZACLO ODT	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		2005-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021590-004	FAZACLO ODT	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2007-05-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021590-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021590-006	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	N021590-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021590-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021590-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021590-006	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-3087-01	EA - Each	0093-3087	dbb50346-b726-4011-8e33-99ea2cca37dd	1	2015-06-09
0093-3087-19	EA - Each	0093-3087	38882b09-0ff0-48dc-a898-3cc8cee48181	1	2015-06-09
0093-3087-84	EA - Each	0093-3087	5fb3064c-63f6-487e-8aa2-11aa489ca8bd	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOZAPINE	ACTIVE INGREDIENT	J60AR2IKIC	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
CLOZAPINE	ACTIVE MOIETY	J60AR2IKIC	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
MINT	INACTIVE INGREDIENT	FV98Z8GITP	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]	11

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-3087-01	00093308701	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-3087-01)	2015-05-05	2022-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clozapine	Teva Pharmaceuticals USA Inc \| Jazz Pharmaceuticals, Inc.	2022-03-03	HUMAN PRESCRIPTION DRUG LABEL	17