Olanzapine

Product NDC
55111-167
11-digit product format
551110167
Labeler code
55111
Product ID
55111-167_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
15 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
OLANZAPINE15 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
55111-167-01Olanzapine100 in 1 BOTTLETABLET, FILM COATED10023
55111-167-05Olanzapine500 in 1 BOTTLETABLET, FILM COATED50023
55111-167-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED3023
55111-167-78Olanzapine10 in 1 CARTONTABLET, FILM COATED1023
55111-167-79Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED1023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-167OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LTD.]23Current NDC, Legacy NDC, 5 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 TabletPSN1705bab2-a2f8-4534-b1fc-eb309cd2696b14
312077OLANZapine 15 MG Oral TabletPSN709d79a1-2742-4629-af43-161be166833a14
283639OLANZapine 20 MG Oral TabletPSN709d79a1-2742-4629-af43-161be166833a14
312077olanzapine 15 MG Oral TabletSCD1705bab2-a2f8-4534-b1fc-eb309cd2696b14
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 TabletPSNc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
312077olanzapine 15 MG Oral TabletSCDc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
283639olanzapine 20 MG Oral TabletSCDc0d705bf-b719-4c7b-b83d-c17d41cbbfad11
312077OLANZapine 15 MG Oral TabletPSN26a554bc-756d-5b70-e063-6394a90a12911
312077olanzapine 15 MG Oral TabletSCD26a554bc-756d-5b70-e063-6394a90a12911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-167-0155111016701100 TABLET, FILM COATED in 1 BOTTLE (55111-167-01) 2012-04-230000-00-00NoNoCurrent
55111-167-0555111016705500 TABLET, FILM COATED in 1 BOTTLE (55111-167-05) 2012-04-230000-00-00NoNoCurrent
55111-167-305511101673030 TABLET, FILM COATED in 1 BOTTLE (55111-167-30) 2012-04-230000-00-00NoNoCurrent
55111-167-785511101677810 BLISTER PACK in 1 CARTON (55111-167-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-167-79) 10 blister pack2012-04-230000-00-00NoNoCurrent
55111-167-795511101677910 in 1 BLISTER PACKHistorical