Olanzapine

Product NDC
70518-0935
11-digit product format
705180935
Labeler code
70518
Product ID
70518-0935_4847cdb9-db33-79ee-e063-6394a90acd9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202862
Marketing category
ANDA
Marketing start
2018-01-05
Substance
OLANZAPINE
Active strength
5 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
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
70518-0935-0Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0935OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 1 package rows20250504_8e5ef52d-315b-4055-9e52-403e6f896f24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN8e5ef52d-315b-4055-9e52-403e6f896f2414
312078olanzapine 5 MG Oral TabletSCD8e5ef52d-315b-4055-9e52-403e6f896f2414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-0935-07051809350030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0935-0) 2018-01-05NoNoHistorical