FDA.reportPublic FDA data

Olanzapine

Product NDC
71335-0534
11-digit product format
713350534
Labeler code
71335
Product ID
71335-0534_337b1be2-1abe-ac1f-e063-6294a90a13a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
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
OLANZAPINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312078

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
71335-0534-1Olanzapine30 in 1 BOTTLETABLET, FILM COATED3014
71335-0534-2Olanzapine15 in 1 BOTTLETABLET, FILM COATED1514
71335-0534-3Olanzapine60 in 1 BOTTLETABLET, FILM COATED6014
71335-0534-4Olanzapine90 in 1 BOTTLETABLET, FILM COATED9014
71335-0534-5Olanzapine120 in 1 BOTTLETABLET, FILM COATED12014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0534-3EA - Each71335-0534c684f263-6a74-4429-a5f7-42d03d9b230d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0534OLANZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 5 package rows20250425_8586e828-34e7-4eb4-a933-6c688927478f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN8586e828-34e7-4eb4-a933-6c688927478f14
312078olanzapine 5 MG Oral TabletSCD8586e828-34e7-4eb4-a933-6c688927478f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0534-17133505340130 TABLET, FILM COATED in 1 BOTTLE (71335-0534-1) 2018-02-210000-00-00NoNoCurrent
71335-0534-27133505340215 TABLET, FILM COATED in 1 BOTTLE (71335-0534-2) 2021-12-270000-00-00NoNoCurrent
71335-0534-37133505340360 TABLET, FILM COATED in 1 BOTTLE (71335-0534-3) 2021-06-010000-00-00NoNoCurrent
71335-0534-47133505340490 TABLET, FILM COATED in 1 BOTTLE (71335-0534-4) 2021-12-270000-00-00NoNoCurrent
71335-0534-571335053405120 TABLET, FILM COATED in 1 BOTTLE (71335-0534-5) 2021-12-270000-00-00NoNoCurrent