Olanzapine

Product NDC
70518-1611
11-digit product format
705181611
Labeler code
70518
Product ID
70518-1611_494f4e23-fd6a-1e40-e063-6394a90ae99f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076255
Marketing category
ANDA
Marketing start
2018-10-29
Substance
OLANZAPINE
Active strength
7.5 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
OLANZAPINE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui312079

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
70518-1611-0Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-1611-1Olanzapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
70518-1611-2Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1611OLANZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250507_68de2a51-69b2-4d99-be79-36a95a4bc475.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312079OLANZapine 7.5 MG Oral TabletPSN68de2a51-69b2-4d99-be79-36a95a4bc47517
312079olanzapine 7.5 MG Oral TabletSCD68de2a51-69b2-4d99-be79-36a95a4bc47517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1611-07051816110030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1611-0) 2018-10-290000-00-00NoNoCurrent
70518-1611-17051816110130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1611-1) 2022-07-280000-00-00NoNoCurrent
70518-1611-27051816110230 TABLET, FILM COATED in 1 BLISTER PACK (70518-1611-2) 2025-02-07NoNoHistorical