FDA.reportPublic FDA data

Olanzapine

Product NDC
68084-528
11-digit product format
680840528
Labeler code
68084
Product ID
68084-528_4b4696c5-89bf-9c39-e063-6294a90aebc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076133
Marketing category
ANDA
Marketing start
2012-05-07
Substance
OLANZAPINE
Active strength
15 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
OLANZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui283639, 312077

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
68084-528-01Olanzapine100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10011
68084-528-11Olanzapine1 in 1 BLISTER PACKTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-528-01EA - Each68084-52830da7dfa-0f64-4b55-a3d0-9a7108c06a6712012-07-24
68084-528-11EA - Each68084-5282cf86d14-92d8-4a5d-ab48-2fb2a16190a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-528OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240522_c0d705bf-b719-4c7b-b83d-c17d41cbbfad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSNc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
283639OLANZapine 20 MG Oral TabletPSNc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
312077olanzapine 15 MG Oral TabletSCDc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
283639olanzapine 20 MG Oral TabletSCDc0d705bf-b719-4c7b-b83d-c17d41cbbfad11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-528-0168084052801100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-528-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-528-11) 100 blister pack2012-05-070000-00-00NoNoCurrent
68084-528-11680840528111 in 1 BLISTER PACKHistorical