Olanzapine

Product NDC
64725-0751
11-digit product format
647250751
Labeler code
64725
Product ID
64725-0751_0c423960-d654-405a-9c7e-75786213899f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA090881
Marketing category
ANDA
Marketing start
2012-02-28
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-0751IInactivated by FDA2026-10-05
excluded packagepackage64725-075164725-0751-1IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64725-0751-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-0751-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-0751-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-0751-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-0751-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-0751-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-0751-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-0751-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-0751-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-0751-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-0751-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-0751-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-0751-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-0751-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-0751-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-0751-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-0751-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-0751-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-0751-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-0751-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-0751-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-0751-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090881-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28
A090881-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28
A090881-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28
A090881-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2884e616aacf4f…
2026-09-14 22:38:342026-08A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2884e616aacf4f…
2026-09-14 22:38:342026-08A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2884e616aacf4f…
2026-09-14 22:38:342026-08A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090881-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090881-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090881-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090881-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORAL2012-02-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A090881-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090881-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090881-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090881-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090881-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090881-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090881-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090881-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090881-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090881-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090881-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090881-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090881-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090881-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090881-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090881-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090881-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090881-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090881-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090881-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090881-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090881-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090881-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090881-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090881-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090881-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090881-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090881-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090881-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090881-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090881-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090881-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090881-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090881-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090881-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090881-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090881-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090881-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090881-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090881-004AB18869cabd3fbd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#