Olanzapine

Product NDC
0093-5770
11-digit product format
000935770
Labeler code
0093
Product ID
0093-5770_69827204-6016-4105-ba6e-4bbda9a82b78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
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
No
Listing certified through
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5770-01EA - Each0093-577008bb6fdc-56c6-4606-8ef8-27edab273e7912012-07-24
0093-5770-10EA - Each0093-57709e670703-033a-4cd5-a284-548205822fa812013-02-13
0093-5770-56EA - Each0093-5770ec1dde40-a18b-46d6-b82b-2df152a5ac1112012-07-24

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
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
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
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 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