Olanzapine

Product NDC
60429-623
11-digit product format
604290623
Labeler code
60429
Product ID
60429-623_5023a1ed-b0d6-44d2-e063-6394a90ae2c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090798
Marketing category
ANDA
Marketing start
2012-04-23
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 283639, 312077, 312078, 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
60429-623-10Olanzapine1000 in 1 BOTTLETABLET, FILM COATED100012
60429-623-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-623OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 2 package rows20250426_a1dfb4e7-4143-4422-b7a7-292e4fd75044.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312077OLANZapine 15 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
200034OLANZapine 2.5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
283639OLANZapine 20 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312078OLANZapine 5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312079OLANZapine 7.5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
314154olanzapine 10 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312077olanzapine 15 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
200034olanzapine 2.5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
283639olanzapine 20 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312078olanzapine 5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312079olanzapine 7.5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-623-10604290623101000 TABLET, FILM COATED in 1 BOTTLE (60429-623-10) 2019-10-160000-00-00NoNoCurrent
60429-623-306042906233030 TABLET, FILM COATED in 1 BOTTLE (60429-623-30) 2019-10-160000-00-00NoNoCurrent