Olanzapine

Product NDC
63629-8719
11-digit product format
636298719
Labeler code
63629
Product ID
63629-8719_3365de4d-4ce3-47f2-e063-6294a90a8633
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091265
Marketing category
ANDA
Marketing start
2011-10-24
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
Rxcui351108

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
63629-8719-1Olanzapine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING30106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8719-1EA - Each63629-871918f79442-9b57-4d19-9e3a-0b52839962b412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8719OLANZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20250424_58f175a8-5549-4f9e-baf4-8dc340c2cfd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351108OLANZapine 20 MG Disintegrating Oral TabletPSN58f175a8-5549-4f9e-baf4-8dc340c2cfd5106
351108olanzapine 20 MG Disintegrating Oral TabletSCD58f175a8-5549-4f9e-baf4-8dc340c2cfd5106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8719-16362987190130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8719-1) 2011-10-240000-00-00NoNoCurrent