Olanzapine

Product NDC
72789-341
11-digit product format
727890341
Labeler code
72789
Product ID
72789-341_31f578dc-776c-d6fa-e063-6394a90a0b26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui283639

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
72789-341-90Olanzapine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-341-90EA - Each72789-34156f03e79-aa28-488f-8373-3ed985a16d1212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-341OLANZAPINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, 1 package rows20250406_b6f0b2e2-3cbd-4564-8b3e-f811589af275.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283639OLANZapine 20 MG Oral TabletPSNb6f0b2e2-3cbd-4564-8b3e-f811589af27514
283639olanzapine 20 MG Oral TabletSCDb6f0b2e2-3cbd-4564-8b3e-f811589af27514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-341-907278903419090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-341-90) 2023-08-01NoNoHistorical