FDA.reportPublic FDA data

Olanzapine

Product NDC
64725-0265
11-digit product format
647250265
Labeler code
64725
Product ID
64725-0265_ecec32e8-eb3f-4c1c-87cd-d459f59ed6fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA076534
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
20 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0265-12020-01-31C16284748780-19d75b9d0-9169-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use olanzapine orally disintegrating tablets safely and effectively. See full prescribing information for olanzapine orally disintegrating tablets. Olanzapine Orally Disintegrating Tablets for Oral use Initial U.S. Approval: 1996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
olanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2