Olanzapine

Product NDC
67296-1722
11-digit product format
672961722
Labeler code
67296
Product ID
67296-1722_b8dfb680-8a9e-5315-e053-2995a90aa59d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076255
Marketing category
ANDA
Marketing start
2019-11-01
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1722-32023-01-30C16284748780-1f386c649-f76b-0266-e053-dadaa90a7c1aOlanzapine 5mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1722-3Olanzapine30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1722OLANZAPINE TABLET, FILM COATED [REDPHARM DRUG, INC.]9Legacy NDC, 1 package rows20210115_96ddc4f5-43be-5d42-e053-2a95a90a5d12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN96ddc4f5-43be-5d42-e053-2a95a90a5d129
312078olanzapine 5 MG Oral TabletSCD96ddc4f5-43be-5d42-e053-2a95a90a5d129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1722-36729617220330 TABLET, FILM COATED in 1 BOTTLE (67296-1722-3) 2019-11-010000-00-00NoNoCurrent