FDA.reportPublic FDA data

Olanzapine

Product NDC
63187-844
11-digit product format
631870844
Labeler code
63187
Product ID
63187-844_e818889d-6a4e-473d-90cc-f817ffece059
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090798
Marketing category
ANDA
Marketing start
2012-04-23
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
Rxcui312078

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
63187-844-03Olanzapine03 in 1 BOTTLETABLET, FILM COATED033
63187-844-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED303
63187-844-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED603
63187-844-90Olanzapine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-844-03EA - Each63187-844adbf9a8c-b5cf-42a8-9fc0-89b1a942496f12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-844OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191113_7772a4c2-1fb1-412b-9e3b-ef3d693517a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSN7772a4c2-1fb1-412b-9e3b-ef3d693517a23
312078olanzapine 5 MG Oral TabletSCD7772a4c2-1fb1-412b-9e3b-ef3d693517a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-844-03631870844033 TABLET, FILM COATED in 1 BOTTLE (63187-844-03) 2017-05-010000-00-00NoNoCurrent
63187-844-306318708443030 TABLET, FILM COATED in 1 BOTTLE (63187-844-30) 2012-04-230000-00-00NoNoCurrent
63187-844-606318708446060 TABLET, FILM COATED in 1 BOTTLE (63187-844-60) 2012-04-230000-00-00NoNoCurrent
63187-844-906318708449090 TABLET, FILM COATED in 1 BOTTLE (63187-844-90) 2017-05-010000-00-00NoNoCurrent