FDA.reportPublic FDA data

Olanzapine

Product NDC
42254-205
11-digit product format
422540205
Labeler code
42254
Product ID
42254-205_d6a92eba-0841-474b-96f3-778f060ab133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076000
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
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
42254-205-302019-09-24C16284748780-19350213a-3be7-c013-e053-90daa90a1393These 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
42254-205-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-205-30EA - Each42254-2055faa9ddf-4b3f-41b0-9a53-60a767cc659f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OlanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
olanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-205OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120621_d6a92eba-0841-474b-96f3-778f060ab133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNd6a92eba-0841-474b-96f3-778f060ab1331
200034OLANZapine 2.5 MG Oral TabletPSNd6a92eba-0841-474b-96f3-778f060ab1331
312078OLANZapine 5 MG Oral TabletPSNd6a92eba-0841-474b-96f3-778f060ab1331
314154olanzapine 10 MG Oral TabletSCDd6a92eba-0841-474b-96f3-778f060ab1331
200034olanzapine 2.5 MG Oral TabletSCDd6a92eba-0841-474b-96f3-778f060ab1331
312078olanzapine 5 MG Oral TabletSCDd6a92eba-0841-474b-96f3-778f060ab1331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-205-304225402053030 in 1 BOTTLEHistorical