FDA.reportPublic FDA data

Olanzapine

Product NDC
68788-7161
11-digit product format
687887161
Labeler code
68788
Product ID
68788-7161_30d1e6c7-87dc-45b2-a999-00ca06ee0ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202862
Marketing category
ANDA
Marketing start
2018-06-05
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312078

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7161-32020-12-01C16284748780-19d75b9cf-ceae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
68788-7161-62020-12-01C16284748780-19d75b9cf-ceae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
68788-7161-92020-12-01C16284748780-19d75b9cf-ceae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
68788-7161-32020-01-31C16284748780-19d75b9cf-ceae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
68788-7161-62020-01-31C16284748780-19d75b9cf-ceae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
68788-7161-92020-01-31C16284748780-19d75b9cf-ceae-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7161-3Olanzapine30 in 1 BOTTLETABLET, FILM COATED307
68788-7161-6Olanzapine60 in 1 BOTTLETABLET, FILM COATED607
68788-7161-9Olanzapine90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7161-3EA - Each68788-7161b471725e-0bc1-476f-982b-04ac5b174bf412018-08-13
68788-7161-6EA - Each68788-7161e743cd8a-1fe2-422b-8ef9-816dc09d557412018-08-13
68788-7161-9EA - Each68788-7161f15b1af6-97a1-4e89-9e8e-96c8c0ef822712018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7161OLANZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20240726_5bded04a-d848-4ac6-b7c3-ff9b9fef3d29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN5bded04a-d848-4ac6-b7c3-ff9b9fef3d297
312078olanzapine 5 MG Oral TabletSCD5bded04a-d848-4ac6-b7c3-ff9b9fef3d297

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7161-36878871610330 TABLET, FILM COATED in 1 BOTTLE (68788-7161-3) 2018-06-050000-00-00NoNoCurrent
68788-7161-66878871610660 TABLET, FILM COATED in 1 BOTTLE (68788-7161-6) 2018-06-050000-00-00NoNoCurrent
68788-7161-96878871610990 TABLET, FILM COATED in 1 BOTTLE (68788-7161-9) 2018-06-050000-00-00NoNoCurrent