FDA.reportPublic FDA data

Olanzapine

Product NDC
63187-364
11-digit product format
631870364
Labeler code
63187
Product ID
63187-364_7af11d56-ef6d-47b7-8119-c30c31ef9cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
10 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
OLANZAPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui314154

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
63187-364-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED304
63187-364-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED604
63187-364-90Olanzapine90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-364-30EA - Each63187-3644e4133db-7174-4825-8d3f-cdd861dc60f412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-364OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221021_1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN1f4a2eaf-3a12-4ebe-b97f-0a7bfbc325724
314154olanzapine 10 MG Oral TabletSCD1f4a2eaf-3a12-4ebe-b97f-0a7bfbc325724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-364-306318703643030 TABLET, FILM COATED in 1 BOTTLE (63187-364-30) 2016-08-010000-00-00NoNoCurrent
63187-364-606318703646060 TABLET, FILM COATED in 1 BOTTLE (63187-364-60) 2016-08-010000-00-00NoNoCurrent
63187-364-906318703649090 TABLET, FILM COATED in 1 BOTTLE (63187-364-90) 2016-08-010000-00-00NoNoCurrent