FDA.reportPublic FDA data

Olanzapine

Product NDC
33342-084
11-digit product format
333420084
Labeler code
33342
Product ID
33342-084_54e61f27-1a30-4d62-8709-f7fe4023eb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203044
Marketing category
ANDA
Marketing start
2015-02-27
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
Rxcui312076, 314155, 351107, 351108

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
33342-084-07Olanzapine30 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING3012
33342-084-11Olanzapine100 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING10012
33342-084-12Olanzapine10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1012
33342-084-12Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
33342-084-44Olanzapine1000 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-084-07EA - Each33342-084af06e3af-8890-4f19-94a2-b28733a60ef512015-09-10
33342-084-11EA - Each33342-0847df3ddc0-d48b-478b-9828-393747ee3cbd12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-084OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 5 package rows20250312_df43938a-3469-40eb-8166-f0a2fd29d6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
351107OLANZapine 15 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
351108OLANZapine 20 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
314155OLANZapine 5 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
312076olanzapine 10 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812
351107olanzapine 15 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812
351108olanzapine 20 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812
314155olanzapine 5 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-084-073334200840730 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-084-07) 2015-02-270000-00-00NoNoCurrent
33342-084-1133342008411100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-084-11) 2015-02-270000-00-00NoNoCurrent
33342-084-123334200841210 BLISTER PACK in 1 CARTON (33342-084-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2015-02-270000-00-00NoNoCurrent
33342-084-44333420084441000 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-084-44) 2015-02-270000-00-00NoNoCurrent