FDA.reportPublic FDA data

Olanzapine

Product NDC
68258-7154
11-digit product format
682587154
Labeler code
68258
Product ID
68258-7154_f546cd57-6d18-4096-a519-c12c62ec817c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA076000
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
8 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
68258-7154-92019-11-27C16284748780-19855d018-dd81-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use olanzapine tablets USP safely and effectively. See full prescribing information for olanzapine tablets USP. OLANZAPINE tablets USP for oral use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-7154-9Olanzapine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-7154OLANZAPINE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20130409_e3d894b3-5cb6-4aab-bd4a-982f73110c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSNe3d894b3-5cb6-4aab-bd4a-982f73110c7c2
200034OLANZapine 2.5 MG Oral TabletPSNe3d894b3-5cb6-4aab-bd4a-982f73110c7c2
312079OLANZapine 7.5 MG Oral TabletPSNe3d894b3-5cb6-4aab-bd4a-982f73110c7c2
312077olanzapine 15 MG Oral TabletSCDe3d894b3-5cb6-4aab-bd4a-982f73110c7c2
200034olanzapine 2.5 MG Oral TabletSCDe3d894b3-5cb6-4aab-bd4a-982f73110c7c2
312079olanzapine 7.5 MG Oral TabletSCDe3d894b3-5cb6-4aab-bd4a-982f73110c7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-7154-96825871540990 in 1 BOTTLEHistorical