FDA.reportPublic FDA data

Olanzapine

Product NDC
71335-0714
11-digit product format
713350714
Labeler code
71335
Product ID
71335-0714_6e70ac3e-a755-4656-be55-a412fe9a9dc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076255
Marketing category
ANDA
Marketing start
2013-12-10
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
71335-0714-1Olanzapine30 in 1 BOTTLETABLET, FILM COATED307
71335-0714-2Olanzapine15 in 1 BOTTLETABLET, FILM COATED157
71335-0714-3Olanzapine60 in 1 BOTTLETABLET, FILM COATED607
71335-0714-4Olanzapine90 in 1 BOTTLETABLET, FILM COATED907
71335-0714-5Olanzapine120 in 1 BOTTLETABLET, FILM COATED1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0714-1EA - Each71335-07146f92b279-2899-4383-b37e-99bdee0c293112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0714OLANZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 5 package rows20230331_09e48e71-4dd2-4538-91d7-5b284f6647d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN09e48e71-4dd2-4538-91d7-5b284f6647d87
312078olanzapine 5 MG Oral TabletSCD09e48e71-4dd2-4538-91d7-5b284f6647d87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0714-17133507140130 TABLET, FILM COATED in 1 BOTTLE (71335-0714-1) 2018-03-020000-00-00NoNoCurrent
71335-0714-27133507140215 TABLET, FILM COATED in 1 BOTTLE (71335-0714-2) 2021-12-270000-00-00NoNoCurrent
71335-0714-37133507140360 TABLET, FILM COATED in 1 BOTTLE (71335-0714-3) 2021-12-270000-00-00NoNoCurrent
71335-0714-47133507140490 TABLET, FILM COATED in 1 BOTTLE (71335-0714-4) 2021-12-270000-00-00NoNoCurrent
71335-0714-571335071405120 TABLET, FILM COATED in 1 BOTTLE (71335-0714-5) 2021-12-270000-00-00NoNoCurrent