FDA.reportPublic FDA data

Olanzapine

Product NDC
71205-487
11-digit product format
712050487
Labeler code
71205
Product ID
71205-487_61424fa3-b09a-4267-a208-a7c7c3f69fe5
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
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
Rxcui312077

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
71205-487-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED301
71205-487-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED601
71205-487-90Olanzapine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-487-30EA - Each71205-487cdb35ce0-4b81-4944-91cd-99b486bae53d12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-487OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20201031_61424fa3-b09a-4267-a208-a7c7c3f69fe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSN61424fa3-b09a-4267-a208-a7c7c3f69fe51
312077olanzapine 15 MG Oral TabletSCD61424fa3-b09a-4267-a208-a7c7c3f69fe51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-487-307120504873030 TABLET, FILM COATED in 1 BOTTLE (71205-487-30) 2020-10-160000-00-00NoNoCurrent
71205-487-607120504876060 TABLET, FILM COATED in 1 BOTTLE (71205-487-60) 2020-10-160000-00-00NoNoCurrent
71205-487-907120504879090 TABLET, FILM COATED in 1 BOTTLE (71205-487-90) 2020-10-160000-00-00NoNoCurrent