Olanzapine

Product NDC
63629-8717
11-digit product format
636298717
Labeler code
63629
Product ID
63629-8717_3363cea7-b182-09e6-e063-6294a90ae027
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
5 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
OLANZAPINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui314155

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
63629-8717-1Olanzapine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8717-1EA - Each63629-87176006338e-def2-41b1-b4a4-0c0d3267482c12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8717OLANZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20250424_d3857220-d9ff-4820-bf53-f2384b59a1a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314155OLANZapine 5 MG Disintegrating Oral TabletPSNd3857220-d9ff-4820-bf53-f2384b59a1a6107
314155olanzapine 5 MG Disintegrating Oral TabletSCDd3857220-d9ff-4820-bf53-f2384b59a1a6107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8717-16362987170130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8717-1) 2011-10-240000-00-00NoNoCurrent