Olanzapine

Product NDC
72303-0843
11-digit product format
723030843
Labeler code
72303
Product ID
72303-0843_4d1b8476-a9ab-067a-e063-6294a90a57c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
HEC Pharm USA Inc.
Application
ANDA208146
Marketing category
ANDA
Marketing start
2026-03-17
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
Rxcui312076, 314155, 351107, 351108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72303-0843-1Olanzapine30 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN4d1b83db-54db-d51f-e063-6394a90a4a691
351107OLANZapine 15 MG Disintegrating Oral TabletPSN4d1b83db-54db-d51f-e063-6394a90a4a691
351108OLANZapine 20 MG Disintegrating Oral TabletPSN4d1b83db-54db-d51f-e063-6394a90a4a691
314155OLANZapine 5 MG Disintegrating Oral TabletPSN4d1b83db-54db-d51f-e063-6394a90a4a691
312076olanzapine 10 MG Disintegrating Oral TabletSCD4d1b83db-54db-d51f-e063-6394a90a4a691
351107olanzapine 15 MG Disintegrating Oral TabletSCD4d1b83db-54db-d51f-e063-6394a90a4a691
351108olanzapine 20 MG Disintegrating Oral TabletSCD4d1b83db-54db-d51f-e063-6394a90a4a691
314155olanzapine 5 MG Disintegrating Oral TabletSCD4d1b83db-54db-d51f-e063-6394a90a4a691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72303-0843-17230308430130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (72303-0843-1) 2026-03-17NoNoHistorical