FDA.reportPublic FDA data

Olanzapine

Product NDC
55111-265
11-digit product format
551110265
Labeler code
55111
Product ID
55111-265_ae2395b5-0918-65db-7001-41d52f121be7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA076534
Marketing category
ANDA
Marketing start
2011-10-24
Substance
OLANZAPINE
Active strength
20 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
OLANZAPINE20 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
55111-265-79Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1020
55111-265-81Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1020
55111-265-81Olanzapine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-265-79EA - Each55111-265529da889-843e-4a08-aee7-7e7384b33ed712014-05-02
55111-265-81EA - Each55111-2658cda0261-8d46-4a46-aca7-0142ef80383d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
olanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
aspartameINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
mannitolINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
olanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-265OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]20Current NDC, Legacy NDC, 3 package rows20250429_aff02cff-d079-bc82-6182-a24c4c6e09a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
351107OLANZapine 15 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
351108OLANZapine 20 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
314155OLANZapine 5 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
312076olanzapine 10 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620
351107olanzapine 15 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620
351108olanzapine 20 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620
314155olanzapine 5 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-265-795511102657910 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-265-79) 2011-10-240000-00-00NoNoCurrent
55111-265-81551110265813 BLISTER PACK in 1 CARTON (55111-265-81) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2011-10-240000-00-00NoNoCurrent