FDA.reportPublic FDA data

Olanzapine

Product NDC
70518-1501
11-digit product format
705181501
Labeler code
70518
Product ID
70518-1501_491155e5-a917-f279-e063-6294a90a8b30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076133
Marketing category
ANDA
Marketing start
2018-10-08
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1501-0Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1501-1Olanzapine28 in 1 BLISTER PACKTABLET, FILM COATED2814

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1501OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 2 package rows20250423_1705bab2-a2f8-4534-b1fc-eb309cd2696b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSN1705bab2-a2f8-4534-b1fc-eb309cd2696b14
312077olanzapine 15 MG Oral TabletSCD1705bab2-a2f8-4534-b1fc-eb309cd2696b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1501-07051815010030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1501-0) 2018-10-080000-00-00NoNoCurrent
70518-1501-17051815010128 TABLET, FILM COATED in 1 BLISTER PACK (70518-1501-1) 2018-10-220000-00-00NoNoCurrent