Olanzapine

Product NDC
49884-320
11-digit product format
498840320
Labeler code
49884
Product ID
49884-320_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
5 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49884-320DDiscontinued by firm2026-08-03
excluded packagepackage49884-32049884-320-55DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 18 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-32049884-320-55DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct49884-320DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-32049884-320-55DDiscontinued 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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
49884-320-52EA - Each49884-320dbf54293-37f7-4cb2-9c69-607408d87bfd12013-02-13
49884-320-55EA - Each49884-32022e777da-fb9c-47ea-ba25-080cd009924012012-07-24

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
314155OLANZapine 5 MG Disintegrating Oral TabletPSN3aa5007a-8547-4991-a51d-59829837ac616
314155olanzapine 5 MG Disintegrating Oral TabletSCD3aa5007a-8547-4991-a51d-59829837ac616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-320-55498840320553 BLISTER PACK in 1 CARTON (49884-320-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-320-52) 3 blister pack2011-10-240000-00-00NoNoCurrent