Olanzapine

Product NDC
49349-931
11-digit product format
493490931
Labeler code
49349
Product ID
49349-931_a3102f3d-3c7a-4b6e-ab6a-1239125d67f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLANZAPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076000
Marketing category
ANDA
Marketing start
2012-12-13
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
10 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49349-931DDiscontinued by firm2026-10-05
excluded productproduct49349-931IInactivated by FDA2026-10-05
excluded packagepackage49349-93149349-931-02DDiscontinued by firm2026-10-05
excluded packagepackage49349-93149349-931-24IInactivated 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 2 · 68 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49349-931-24IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49349-931-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49349-931-24IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49349-931-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49349-931-24IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49349-931-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49349-931-24IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49349-931-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49349-931-24IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49349-931-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49349-931-24IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49349-931-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49349-931-24IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49349-931-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49349-931-24IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49349-931-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49349-931-24IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49349-931-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49349-931-24IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49349-931-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49349-931-24IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49349-931-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49349-931-24IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49349-931-02DDiscontinued by firm557ba5c1ecfa…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 packagepackage49349-931-24IInactivated 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 packagepackage49349-931-24IInactivated 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 packagepackage49349-931-24IInactivated 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 packagepackage49349-931-24IInactivated 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 packagepackage49349-931-24IInactivated 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 packagepackage49349-931-24IInactivated by FDAbd6a592717d7…303034d00443…

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

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
A076000-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORAL2011-10-24
A076000-002OLANZAPINEOLANZAPINE5MGTABLET / ORAL2011-10-24
A076000-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORAL2011-10-24
A076000-004OLANZAPINEOLANZAPINE10MGTABLET / ORAL2011-10-24
A076000-005OLANZAPINEOLANZAPINE15MGTABLET / ORAL2011-10-24

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-2484e616aacf4f…
2026-09-14 22:38:342026-08A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-2484e616aacf4f…
2026-09-14 22:38:342026-08A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-2484e616aacf4f…
2026-09-14 22:38:342026-08A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-2484e616aacf4f…
2026-09-14 22:38:342026-08A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-2484e616aacf4f…
2026-08-18 06:07:402026-07A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076000-001OLANZAPINE2.5MGTABLET / ORAL2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076000-002OLANZAPINE5MGTABLET / ORAL2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076000-003OLANZAPINE7.5MGTABLET / ORAL2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076000-004OLANZAPINE10MGTABLET / ORAL2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076000-005OLANZAPINE15MGTABLET / ORAL2011-10-2403ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076000-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076000-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076000-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076000-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076000-005AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076000-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076000-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076000-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076000-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076000-005AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076000-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076000-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076000-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076000-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076000-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076000-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076000-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076000-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076000-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076000-005AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49349-931-242019-11-27C16284748780-19855d018-e0a8-cd31-e053-dbdaa90ab51a3fa66f49-e3c3-42b2-ad32-dd376fb9de85