FDA.reportPublic FDA data

Olanzapine

Product NDC
65862-656
11-digit product format
658620656
Labeler code
65862
Product ID
65862-656_4f9fe058-fa71-4b85-9bad-482ade6b085e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203708
Marketing category
ANDA
Marketing start
2014-05-15
Substance
OLANZAPINE
Active strength
5 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
OLANZAPINE5 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
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-656-03Olanzapine03 in 1 CARTONTABLET, ORALLY DISINTEGRATING0316
65862-656-10Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-656-03EA - Each65862-65667975bb1-66c9-4977-bdc6-a2c0a785ee5d12015-06-09
65862-656-10EA - Each65862-6564f1a6ef6-972e-4b63-b43c-d147b72debbd12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-656OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 2 package rows20250312_4d768cfe-3b20-4127-95b9-b4151b28afcc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-656-03658620656033 BLISTER PACK in 1 CARTON (65862-656-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-656-10) 3 blister pack2014-05-150000-00-00NoNoCurrent
65862-656-106586206561010 in 1 BLISTER PACKHistorical
65862-656-296586206562920000 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-656-29)15-MAY-14Current