Clozapine

Product NDC
0093-3012
11-digit product format
000933012
Labeler code
0093
Product ID
0093-3012_84b5f375-b261-4259-beb6-00160eaf0fb6
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
2012-08-30
Marketing end
2019-11-30
Substance
CLOZAPINE
Active strength
25 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-3012DDiscontinued by firm2026-08-17
excluded packagepackage0093-30120093-3012-01DDiscontinued by firm2026-08-17
excluded packagepackage0093-30120093-3012-84DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-3012-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-3012-84d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-3012-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-3012-84f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-3012-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-3012-842ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-3012-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-3012-84a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-3012-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-3012-84cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-3012-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-3012-84cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-3012-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-3012-84302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-3012-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-3012-84ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-3012-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-3012-840efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-3012-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-3012-84ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-3012-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-3012-84367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-3012-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-3012-84557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021590-001FAZACLO ODTCLOZAPINE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10
N021590-002FAZACLO ODTCLOZAPINE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10
N021590-003FAZACLO ODTCLOZAPINE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-03
N021590-004FAZACLO ODTCLOZAPINE12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30
N021590-005FAZACLO ODTCLOZAPINE150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09
N021590-006FAZACLO ODTCLOZAPINE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-3003ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021590-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-006AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09N021590-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021590-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-006AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3012-01EA - Each0093-3012865dcca1-5d00-4ec0-934e-44f595cd357b12013-02-13
0093-3012-19EA - Each0093-301272df6856-d386-4312-a7e3-fa41d17d14dc12013-02-13
0093-3012-84EA - Each0093-3012cac93bdf-21f9-4c7e-ae02-1c0e485d1b9412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOZAPINEACTIVE INGREDIENTJ60AR2IKICCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CLOZAPINEACTIVE MOIETYJ60AR2IKICCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
MANNITOLINACTIVE INGREDIENT3OWL53L36ACLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
MINTINACTIVE INGREDIENTFV98Z8GITPCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC]11