Olanzapine

Product NDC
55154-5896
11-digit product format
551545896
Labeler code
55154
Product ID
55154-5896_7d0235dc-b4e8-4f39-a877-4f547c67a9cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076255
Marketing category
ANDA
Marketing start
2012-04-23
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5896OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]9Legacy NDC20241122_120b31d1-4d56-4f28-8a90-dfcb9ad78d9c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5896-05515458960010 BLISTER PACK in 1 BAG (55154-5896-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-04-230000-00-00NoNoCurrent