Olanzapine

Product NDC
0093-5105
11-digit product format
000935105
Labeler code
0093
Product ID
0093-5105_6477c607-c26d-7ae9-1554-30f225c88415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA Inc
Application
ANDA076133
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
2019-05-31
Substance
OLANZAPINE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5105-01EA - Each0093-5105c53b5209-1153-46a1-8088-a5c5cf6afba112012-07-24
0093-5105-05EA - Each0093-51053fd8762b-6bcc-4924-8c13-8535ec8d2d5812012-07-24
0093-5105-56EA - Each0093-510551173b72-d717-47cd-8ba3-e793d34751f512012-07-24

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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283639OLANZapine 20 MG Oral TabletPSNd976599a-0ee0-4fa4-afe6-bdfbca570afe1
283639olanzapine 20 MG Oral TabletSCDd976599a-0ee0-4fa4-afe6-bdfbca570afe1