Olanzapine

Product NDC
43598-165
11-digit product format
435980165
Labeler code
43598
Product ID
43598-165_9f9b5830-1420-24fc-73be-4a040ccb22db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA076255
Marketing category
ANDA
Marketing start
2013-12-10
Substance
OLANZAPINE
Active strength
7.5 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
OLANZAPINE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312078, 312079, 314154

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
43598-165-01Olanzapine100 in 1 BOTTLETABLET, FILM COATED10013
43598-165-05Olanzapine500 in 1 BOTTLETABLET, FILM COATED50013
43598-165-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED3013
43598-165-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED6013
43598-165-78Olanzapine10 in 1 CARTONTABLET, FILM COATED1013
43598-165-79Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-165OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.]13Current NDC, Legacy NDC, 6 package rows20250429_d474d5a9-d338-511d-5823-567c0a1bbf4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312079OLANZapine 7.5 MG Oral TabletPSN68de2a51-69b2-4d99-be79-36a95a4bc47517
312079olanzapine 7.5 MG Oral TabletSCD68de2a51-69b2-4d99-be79-36a95a4bc47517
314154OLANZapine 10 MG Oral TabletPSNd474d5a9-d338-511d-5823-567c0a1bbf4d13
312078OLANZapine 5 MG Oral TabletPSNd474d5a9-d338-511d-5823-567c0a1bbf4d13
312079OLANZapine 7.5 MG Oral TabletPSNd474d5a9-d338-511d-5823-567c0a1bbf4d13
314154olanzapine 10 MG Oral TabletSCDd474d5a9-d338-511d-5823-567c0a1bbf4d13
312078olanzapine 5 MG Oral TabletSCDd474d5a9-d338-511d-5823-567c0a1bbf4d13
312079olanzapine 7.5 MG Oral TabletSCDd474d5a9-d338-511d-5823-567c0a1bbf4d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-165-0143598016501100 TABLET, FILM COATED in 1 BOTTLE (43598-165-01) 2013-12-100000-00-00NoNoCurrent
43598-165-0543598016505500 TABLET, FILM COATED in 1 BOTTLE (43598-165-05) 2013-12-100000-00-00NoNoCurrent
43598-165-304359801653030 TABLET, FILM COATED in 1 BOTTLE (43598-165-30) 2013-12-100000-00-00NoNoCurrent
43598-165-604359801656060 TABLET, FILM COATED in 1 BOTTLE (43598-165-60) 2013-12-100000-00-00NoNoCurrent
43598-165-784359801657810 BLISTER PACK in 1 CARTON (43598-165-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-165-79) 10 blister pack2013-12-100000-00-00NoNoCurrent
43598-165-794359801657910 in 1 BLISTER PACKHistorical