FDA.reportPublic FDA data

Olanzapine

Product NDC
70518-2375
11-digit product format
705182375
Labeler code
70518
Product ID
70518-2375_4a065965-43be-e0e3-e063-6294a90ad76a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202862
Marketing category
ANDA
Marketing start
2019-10-23
Substance
OLANZAPINE
Active strength
15 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
OLANZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312077

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
70518-2375-02023-03-09C16284748780-1f386c64a-220f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
70518-2375-02023-01-30C16284748780-1f386c64a-220f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2375-0Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-2375-1Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2375OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250124_76a6ff21-7157-4213-8073-35837a3ac07e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSN76a6ff21-7157-4213-8073-35837a3ac07e9
312077olanzapine 15 MG Oral TabletSCD76a6ff21-7157-4213-8073-35837a3ac07e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2375-07051823750030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2375-0) 2019-10-230000-00-00NoNoCurrent
70518-2375-17051823750130 TABLET, FILM COATED in 1 BLISTER PACK (70518-2375-1) 2025-01-22NoNoHistorical