Olanzapine

Product NDC
67046-1611
11-digit product format
670461611
Labeler code
67046
Product ID
67046-1611_42d9a654-670f-9d73-e063-6394a90a99f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA210022
Marketing category
ANDA
Marketing start
2025-11-05
Substance
OLANZAPINE
Active strength
2.5 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
OLANZAPINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034

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
67046-1611-3Olanzapine30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200034OLANZapine 2.5 MG Oral TabletPSN42d9ad47-52cc-ad11-e063-6394a90aedca1
200034olanzapine 2.5 MG Oral TabletSCD42d9ad47-52cc-ad11-e063-6394a90aedca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1611-36704616110330 TABLET in 1 BLISTER PACK (67046-1611-3) 30 tablet2025-11-05NoNoHistorical