Clozapine

Product NDC
0093-4404
11-digit product format
000934404
Labeler code
0093
Product ID
0093-4404_8af1990e-0b06-424f-9ff8-52ac6428f28c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clozapine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076809
Marketing category
ANDA
Marketing start
2007-03-19
Marketing end
2023-02-28
Substance
CLOZAPINE
Active strength
50 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-4404DDiscontinued by firm2026-08-17
excluded packagepackage0093-44040093-4404-01DDiscontinued by firm2026-08-17
excluded packagepackage0093-44040093-4404-05DDiscontinued by firm2026-08-17
excluded packagepackage0093-44040093-4404-93DDiscontinued 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 · 48 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 packagepackage0093-4404-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-4404-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-4404-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-4404-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-4404-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-4404-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-4404-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-4404-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-4404-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-4404-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-4404-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-4404-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-4404-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-4404-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-4404-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-4404-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-4404-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-4404-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-4404-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-4404-93302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-4404-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-4404-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-4404-93ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-4404-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-4404-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-4404-930efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-4404-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-4404-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-4404-93ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-4404-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-4404-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-4404-93367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-4404-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-4404-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-4404-93557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-4404-05557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076809-001CLOZAPINECLOZAPINE200MGTABLET / ORALAB2005-12-16
A076809-002CLOZAPINECLOZAPINE100MGTABLET / ORALAB2005-12-16
A076809-003CLOZAPINECLOZAPINE50MGTABLET / ORALAB2005-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076809-001AB
A076809-002AB
A076809-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076809-002CLOZAPINE100MGTABLET / ORALAB2005-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076809-003CLOZAPINE50MGTABLET / ORALAB2005-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076809-001CLOZAPINE200MGTABLET / ORALAB2005-12-161e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076809-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076809-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076809-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076809-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076809-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076809-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076809-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076809-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076809-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076809-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076809-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076809-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076809-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076809-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076809-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076809-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076809-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076809-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076809-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076809-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076809-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076809-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076809-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076809-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076809-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076809-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076809-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076809-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076809-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076809-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076809-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076809-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076809-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076809-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076809-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076809-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076809-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076809-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076809-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076809-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4404-01EA - Each0093-4404c6a7f192-011d-4a7e-9db0-e48e985326e012012-07-24
0093-4404-05EA - Each0093-44042a1083bc-bb5e-4773-ab92-69365288177712012-07-24
0093-4404-19EA - Each0093-4404b809a7cc-5ec3-488d-8d4d-f8427f87257712012-07-24
0093-4404-93EA - Each0093-4404a5e75a10-6020-4e8d-a642-f1c19a4087ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOZAPINEACTIVE INGREDIENTJ60AR2IKICCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
CLOZAPINEACTIVE MOIETYJ60AR2IKICCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20
TALCINACTIVE INGREDIENT7SEV7J4R1UCLOZAPINE TABLET [TEVA PHARMACEUTICALS USA INC]20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4404-0100093440401100 TABLET in 1 BOTTLE (0093-4404-01) 100 tablet2007-03-190000-00-00NoNoCurrent
0093-4404-0500093440405500 TABLET in 1 BOTTLE (0093-4404-05) 500 tablet2007-03-190000-00-00NoNoCurrent
0093-4404-9300093440493100 BLISTER PACK in 1 BOX, UNIT-DOSE (0093-4404-93) > 1 TABLET in 1 BLISTER PACK (0093-4404-19) 100 blister pack2007-08-030000-00-00NoNoCurrent