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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-347DDiscontinued by firm2026-10-15
excluded packagepackage57664-34757664-347-13DDiscontinued by firm2026-10-15
excluded packagepackage57664-34757664-347-88DDiscontinued by firm2026-10-15

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 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 packagepackage57664-347-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-347-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-347-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-347-88f5e01cc5f278…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075713-001CLOZAPINECLOZAPINE25MGTABLET / ORAL2002-11-15
A075713-002CLOZAPINECLOZAPINE100MGTABLET / ORAL2002-11-15
A075713-003CLOZAPINECLOZAPINE50MGTABLET / ORAL2005-08-19
A075713-004CLOZAPINECLOZAPINE200MGTABLET / ORAL2017-11-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075713-001CLOZAPINE25MGTABLET / ORAL2002-11-15c2088c7a36db…
2026-10-15 13:18:302026-09A075713-002CLOZAPINE100MGTABLET / ORAL2002-11-15c2088c7a36db…
2026-10-15 13:18:302026-09A075713-003CLOZAPINE50MGTABLET / ORAL2005-08-19c2088c7a36db…
2026-10-15 13:18:302026-09A075713-004CLOZAPINE200MGTABLET / ORAL2017-11-07c2088c7a36db…
2026-09-14 22:38:342026-08A075713-001CLOZAPINE25MGTABLET / ORAL2002-11-1584e616aacf4f…
2026-09-14 22:38:342026-08A075713-002CLOZAPINE100MGTABLET / ORAL2002-11-1584e616aacf4f…
2026-09-14 22:38:342026-08A075713-003CLOZAPINE50MGTABLET / ORAL2005-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A075713-004CLOZAPINE200MGTABLET / ORAL2017-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A075713-001CLOZAPINE25MGTABLET / ORAL2002-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A075713-002CLOZAPINE100MGTABLET / ORAL2002-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A075713-003CLOZAPINE50MGTABLET / ORAL2005-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A075713-004CLOZAPINE200MGTABLET / ORAL2017-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075713-001CLOZAPINE25MGTABLET / ORAL2002-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075713-002CLOZAPINE100MGTABLET / ORAL2002-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075713-003CLOZAPINE50MGTABLET / ORAL2005-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075713-004CLOZAPINE200MGTABLET / ORAL2017-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075713-001CLOZAPINE25MGTABLET / ORAL2002-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075713-002CLOZAPINE100MGTABLET / ORAL2002-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075713-003CLOZAPINE50MGTABLET / ORAL2005-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075713-004CLOZAPINE200MGTABLET / ORAL2017-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075713-001CLOZAPINE25MGTABLET / ORAL2002-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075713-002CLOZAPINE100MGTABLET / ORAL2002-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075713-003CLOZAPINE50MGTABLET / ORAL2005-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075713-004CLOZAPINE200MGTABLET / ORAL2017-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075713-001CLOZAPINE25MGTABLET / ORALAB2002-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075713-002CLOZAPINE100MGTABLET / ORALAB2002-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075713-003CLOZAPINE50MGTABLET / ORALAB2005-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075713-004CLOZAPINE200MGTABLET / ORALAB2017-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075713-001CLOZAPINE25MGTABLET / ORALAB2002-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075713-002CLOZAPINE100MGTABLET / ORALAB2002-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075713-003CLOZAPINE50MGTABLET / ORALAB2005-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075713-004CLOZAPINE200MGTABLET / ORALAB2017-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075713-001CLOZAPINE25MGTABLET / ORALAB2002-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075713-002CLOZAPINE100MGTABLET / ORALAB2002-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075713-003CLOZAPINE50MGTABLET / ORALAB2005-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075713-004CLOZAPINE200MGTABLET / ORALAB2017-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075713-001CLOZAPINE25MGTABLET / ORALAB2002-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075713-002CLOZAPINE100MGTABLET / ORALAB2002-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075713-003CLOZAPINE50MGTABLET / ORALAB2005-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075713-004CLOZAPINE200MGTABLET / ORALAB2017-11-072680178bc6a6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075713-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075713-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075713-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075713-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075713-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A075713-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A075713-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A075713-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075713-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A075713-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A075713-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A075713-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075713-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075713-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075713-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075713-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075713-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A075713-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A075713-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A075713-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075713-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A075713-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A075713-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A075713-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075713-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075713-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075713-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075713-004AB1cb3db0bc1861…

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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-347-13EA - Each57664-34732cae948-9a7a-4c8e-bfce-9a8c1237b81612012-07-24
57664-347-88EA - Each57664-347892d4a57-af36-489b-9eaa-a5bc4974da4c12012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-347-1357664034713500 TABLET in 1 BOTTLE (57664-347-13) 500 tablet2002-11-150000-00-00NoNoCurrent
57664-347-8857664034788100 TABLET in 1 BOTTLE (57664-347-88) 100 tablet2002-11-150000-00-00NoNoCurrent