FDA.reportPublic FDA data

Olanzapine

Product NDC
59746-307
11-digit product format
597460307
Labeler code
59746
Product ID
59746-307_fddf60eb-156f-4e8c-9bad-3942d714fdce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA200221
Marketing category
ANDA
Marketing start
2012-09-13
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-307-322024-12-11C16284748780-1f386c649-9a39-0266-e053-dadaa90a7c1aThese 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
59746-307-322023-01-30C16284748780-1f386c649-9a39-0266-e053-dadaa90a7c1aThese 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-307-12Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1017
59746-307-32Olanzapine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING317

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-307-12EA - Each59746-3074a4a9741-66e9-4ea6-89a8-c825d7ac44bf12013-03-03
59746-307-32EA - Each59746-307ba081004-e5cf-4e22-b42b-1e2d116f902812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OlanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
OlanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
AspartameINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Hydroxypropyl Cellulose, Low SubstitutedINACTIVE INGREDIENT2165RE0K14OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
MannitolINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-307OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20250424_028aa88e-fa50-7aa8-cc0b-97c0c9a0357c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351107OLANZapine 15 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351108OLANZapine 20 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
314155OLANZapine 5 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
312076olanzapine 10 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351107olanzapine 15 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351108olanzapine 20 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
314155olanzapine 5 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-307-125974603071210 in 1 BLISTER PACKHistorical
59746-307-32597460307323 BLISTER PACK in 1 CARTON (59746-307-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-307-12) 3 blister pack2012-09-130000-00-00NoNoCurrent