FDA.reportPublic FDA data

Olanzapine

Product NDC
71335-1760
11-digit product format
713351760
Labeler code
71335
Product ID
71335-1760_34f3d0ae-813c-3d96-e063-6294a90adaf4
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
2.5 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
OLANZAPINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034

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
71335-1760-1Olanzapine30 in 1 BOTTLETABLET, FILM COATED30103
71335-1760-2Olanzapine15 in 1 BOTTLETABLET, FILM COATED15103
71335-1760-3Olanzapine28 in 1 BOTTLETABLET, FILM COATED28103
71335-1760-4Olanzapine60 in 1 BOTTLETABLET, FILM COATED60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1760-1EA - Each71335-1760c50d6c07-d72e-4f9a-aa3b-ca967f85ea0712023-12-05
71335-1760-4EA - Each71335-17609d311d56-e6da-477f-bd57-056af6b191be12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1760OLANZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20250514_dcf8fcbf-636c-41ad-8084-c65ac2f117cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200034OLANZapine 2.5 MG Oral TabletPSNdcf8fcbf-636c-41ad-8084-c65ac2f117cc103
200034olanzapine 2.5 MG Oral TabletSCDdcf8fcbf-636c-41ad-8084-c65ac2f117cc103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1760-17133517600130 TABLET, FILM COATED in 1 BOTTLE (71335-1760-1) 2021-01-180000-00-00NoNoCurrent
71335-1760-27133517600215 TABLET, FILM COATED in 1 BOTTLE (71335-1760-2) 2021-01-180000-00-00NoNoCurrent
71335-1760-37133517600328 TABLET, FILM COATED in 1 BOTTLE (71335-1760-3) 2021-01-180000-00-00NoNoCurrent
71335-1760-47133517600460 TABLET, FILM COATED in 1 BOTTLE (71335-1760-4) 2021-01-180000-00-00NoNoCurrent