Olanzapine

Product NDC
49884-321
11-digit product format
498840321
Labeler code
49884
Product ID
49884-321_c4415910-1493-4b5d-9723-94ae2f6c2622
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA078109
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct49884-321DDiscontinued by firm2026-08-03
excluded packagepackage49884-32149884-321-55DDiscontinued by firm2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct49884-321DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-32149884-321-55DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078109-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A078109-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A078109-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A078109-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078109-001AB
A078109-002AB
A078109-003AB
A078109-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078109-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078109-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078109-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078109-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078109-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078109-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078109-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078109-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078109-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078109-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078109-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078109-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078109-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078109-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078109-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078109-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078109-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078109-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078109-004AB1d06236e962d9…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEStrides Pharma Science Limited979c3212-36e8-4287-aace-bef0875188d72026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078109
application number: ANDA078109

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-321-52EA - Each49884-32124ba7eaa-da74-4286-869e-a9d794c4737a12013-02-13
49884-321-55EA - Each49884-321c3e092d2-7419-4730-bc87-21186002ad8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL, INC.]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL, INC.]3
MAGNESIUM SULFATE, UNSPECIFIEDINACTIVE INGREDIENTDE08037SABOLANZAPINE TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN8ff9fc66-8367-445b-bb35-f6b112543d366
312076olanzapine 10 MG Disintegrating Oral TabletSCD8ff9fc66-8367-445b-bb35-f6b112543d366

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-321-55498840321553 BLISTER PACK in 1 CARTON (49884-321-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-321-52) 3 blister pack2011-10-240000-00-00NoNoCurrent