Clozapine

Product NDC
48433-024
11-digit product format
484330024
Labeler code
48433
Product ID
48433-024_4c992fd8-c815-bfb3-e063-6294a90a8e6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clozapine
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA075417
Marketing category
ANDA
Marketing start
2026-02-23
Substance
CLOZAPINE
Active strength
100 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075417-001CLOZAPINECLOZAPINE25MGTABLET / ORALAB1999-05-27
A075417-002CLOZAPINECLOZAPINE100MGTABLET / ORALAB1999-05-27
A075417-003CLOZAPINECLOZAPINE12.5MGTABLET / ORAL2010-04-15
A075417-004CLOZAPINECLOZAPINE50MGTABLET / ORALAB2010-04-15
A075417-005CLOZAPINECLOZAPINE200MGTABLET / ORALAB2010-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075417-001AB
A075417-002AB
A075417-004AB
A075417-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-001CLOZAPINE25MGTABLET / ORALAB1999-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-002CLOZAPINE100MGTABLET / ORALAB1999-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-003CLOZAPINE12.5MGTABLET / ORAL2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-004CLOZAPINE50MGTABLET / ORALAB2010-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-005CLOZAPINE200MGTABLET / ORALAB2010-04-152680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075417-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075417-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075417-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075417-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075417-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075417-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075417-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075417-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075417-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075417-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075417-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075417-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075417-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075417-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075417-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075417-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075417-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075417-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075417-005AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Clozapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOZAPINE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J60AR2IKICInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197535Internal RxNorm lookup
197536Internal RxNorm lookup
309374Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fa59238-f0a6-4d00-9d8d-df2a43718fc1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fde12e54-43fa-cc16-3015-4c000a7b8d3eProduct name520250812
0901063f-b37f-4bf1-8be6-1e2a469e57bcProduct name220180209
e01fb60f-a608-2c68-dfdd-23e6433ece68Product name520180209
7a7f58c4-be43-7e82-4dfc-128bbed4230aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-024-01Clozapine1 in 1 BLISTER PACKTABLET12
48433-024-20Clozapine100 in 1 CARTONTABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-024-20EA - Each48433-024c8fc6776-dff8-419f-b3a6-1b9a4fecbbd212026-05-22

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClozapineCLOZAPINEMylan Pharmaceuticals Inc.883b5d43-0339-7dc1-f775-93791fb9b9782026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075417
application number: ANDA075417
ClozapineCLOZAPINESafecor Health LLC0fa59238-f0a6-4d00-9d8d-df2a43718fc12026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075417
application number: ANDA075417
ndc (product): 48433-024
ClozapineCLOZAPINEMylan Institutional Inc.d5c8a456-6f3c-4963-b321-4ed746f690e42025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075417
application number: ANDA075417

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197535cloZAPine 100 MG Oral TabletPSN0fa59238-f0a6-4d00-9d8d-df2a43718fc12
309374cloZAPine 200 MG Oral TabletPSN0fa59238-f0a6-4d00-9d8d-df2a43718fc12
197536cloZAPine 25 MG Oral TabletPSN0fa59238-f0a6-4d00-9d8d-df2a43718fc12
197535clozapine 100 MG Oral TabletSCD0fa59238-f0a6-4d00-9d8d-df2a43718fc12
309374clozapine 200 MG Oral TabletSCD0fa59238-f0a6-4d00-9d8d-df2a43718fc12
197536clozapine 25 MG Oral TabletSCD0fa59238-f0a6-4d00-9d8d-df2a43718fc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-024-01484330024011 in 1 BLISTER PACKHistorical
48433-024-2048433002420100 BLISTER PACK in 1 CARTON (48433-024-20) / 1 TABLET in 1 BLISTER PACK (48433-024-01) 100 blister pack2026-02-23NoNoCurrent