FDA.reportPublic FDA data

Olanzapine

Product NDC
68788-8722
11-digit product format
687888722
Labeler code
68788
Product ID
68788-8722_abb81337-86aa-40de-852c-f42dafe5cc56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076255
Marketing category
ANDA
Marketing start
2024-08-09
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
68788-8722-3Olanzapine30 in 1 BOTTLETABLET, FILM COATED302
68788-8722-6Olanzapine60 in 1 BOTTLETABLET, FILM COATED602
68788-8722-9Olanzapine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8722-3EA - Each68788-87227450152c-78f4-4782-a2ab-a928a74d9f9712024-09-09
68788-8722-6EA - Each68788-8722e1226769-4465-4331-9eb5-a8cfe764f66212024-09-09
68788-8722-9EA - Each68788-8722de12e2a2-e8f3-43c5-9109-0e984a231f0d12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8722OLANZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240810_d349d5b7-5658-46d6-9bba-e6f6361cebb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSNd349d5b7-5658-46d6-9bba-e6f6361cebb92
312078olanzapine 5 MG Oral TabletSCDd349d5b7-5658-46d6-9bba-e6f6361cebb92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8722-36878887220330 TABLET, FILM COATED in 1 BOTTLE (68788-8722-3) 2024-08-09NoNoHistorical
68788-8722-66878887220660 TABLET, FILM COATED in 1 BOTTLE (68788-8722-6) 2024-08-09NoNoHistorical
68788-8722-96878887220990 TABLET, FILM COATED in 1 BOTTLE (68788-8722-9) 2024-08-09NoNoHistorical