FDA.reportPublic FDA data

Olanzapine

Product NDC
55111-168
11-digit product format
551110168
Labeler code
55111
Product ID
55111-168_e0d25a13-d2e2-0299-98bb-4d523d75cb76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Ltd.
Application
ANDA076133
Marketing category
ANDA
Marketing start
2012-04-23
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
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
55111-168-01Olanzapine100 in 1 BOTTLETABLET, FILM COATED10023
55111-168-05Olanzapine500 in 1 BOTTLETABLET, FILM COATED50023
55111-168-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED3023
55111-168-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED6023
55111-168-78Olanzapine10 in 1 CARTONTABLET, FILM COATED1023
55111-168-79Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-168-05EA - Each55111-168f8498687-b147-420e-b81d-63ab51d2784b12012-07-24
55111-168-30EA - Each55111-16843dfc9a3-a788-45a9-8f6d-cc01df72d08912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LTD.]15
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]6
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
55111-168OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LTD.]23Current NDC, Legacy NDC, 6 package rows20250429_a4c525da-c2f6-b804-af49-601295922254.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSNa4c525da-c2f6-b804-af49-60129592225423
283639OLANZapine 20 MG Oral TabletPSNa4c525da-c2f6-b804-af49-60129592225423
312077olanzapine 15 MG Oral TabletSCDa4c525da-c2f6-b804-af49-60129592225423
283639olanzapine 20 MG Oral TabletSCDa4c525da-c2f6-b804-af49-60129592225423
312077OLANZapine 15 MG Oral TabletPSN709d79a1-2742-4629-af43-161be166833a14
283639OLANZapine 20 MG Oral TabletPSN709d79a1-2742-4629-af43-161be166833a14
312077olanzapine 15 MG Oral TabletSCD709d79a1-2742-4629-af43-161be166833a14
283639olanzapine 20 MG Oral TabletSCD709d79a1-2742-4629-af43-161be166833a14
312077OLANZapine 15 MG Oral TabletPSNc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
283639OLANZapine 20 MG Oral TabletPSNad350abc-a1fc-4be4-b2be-c629121552a011
283639OLANZapine 20 MG Oral TabletPSNc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
312077olanzapine 15 MG Oral TabletSCDc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
283639olanzapine 20 MG Oral TabletSCDad350abc-a1fc-4be4-b2be-c629121552a011
283639olanzapine 20 MG Oral TabletSCDc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
283639OLANZapine 20 MG Oral TabletPSN51b508ff-dc55-ff36-e063-6294a90a900f1
283639olanzapine 20 MG Oral TabletSCD51b508ff-dc55-ff36-e063-6294a90a900f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-168-0155111016801100 TABLET, FILM COATED in 1 BOTTLE (55111-168-01) 2012-04-230000-00-00NoNoCurrent
55111-168-0555111016805500 TABLET, FILM COATED in 1 BOTTLE (55111-168-05) 2012-04-230000-00-00NoNoCurrent
55111-168-305511101683030 TABLET, FILM COATED in 1 BOTTLE (55111-168-30) 2012-04-230000-00-00NoNoCurrent
55111-168-605511101686060 TABLET, FILM COATED in 1 BOTTLE (55111-168-60) 2012-04-230000-00-00NoNoCurrent
55111-168-785511101687810 BLISTER PACK in 1 CARTON (55111-168-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-168-79) 10 blister pack2012-04-230000-00-00NoNoCurrent
55111-168-795511101687910 in 1 BLISTER PACKHistorical