Olanzapine

Product NDC
63629-8714
11-digit product format
636298714
Labeler code
63629
Product ID
63629-8714_33629b13-1f42-05cd-e063-6294a90ada76
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
15 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
OLANZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui351107

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
63629-8714-1Olanzapine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8714-1EA - Each63629-871490f74bc4-d0b0-4edb-a8be-8b0ebe4634cf12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8714OLANZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20250424_d5a9f78e-56f4-4249-800c-5f52a99fa84b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351107OLANZapine 15 MG Disintegrating Oral TabletPSNd5a9f78e-56f4-4249-800c-5f52a99fa84b107
351107olanzapine 15 MG Disintegrating Oral TabletSCDd5a9f78e-56f4-4249-800c-5f52a99fa84b107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8714-16362987140130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8714-1) 2011-10-240000-00-00NoNoCurrent