Olanzapine

Product NDC
55154-6889
11-digit product format
551546889
Labeler code
55154
Product ID
55154-6889_ce9eff03-1df5-4804-97e9-800aa0d5e22e
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
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312078, 314154

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-6889-0Olanzapine10 in 1 BAGTABLET, FILM COATED1014
55154-6889-0Olanzapine1 in 1 BLISTER PACKTABLET, FILM COATED114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6889OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20250406_38a89689-efc2-4931-8f65-868dc0248d6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN38a89689-efc2-4931-8f65-868dc0248d6a14
312078OLANZapine 5 MG Oral TabletPSN38a89689-efc2-4931-8f65-868dc0248d6a14
314154olanzapine 10 MG Oral TabletSCD38a89689-efc2-4931-8f65-868dc0248d6a14
312078olanzapine 5 MG Oral TabletSCD38a89689-efc2-4931-8f65-868dc0248d6a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-6889-05515468890010 BLISTER PACK in 1 BAG (55154-6889-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-04-230000-00-00NoNoCurrent