FDA.reportPublic FDA data

Olanzapine

Product NDC
82804-067
11-digit product format
828040067
Labeler code
82804
Product ID
82804-067_024e8e9b-a4fc-4882-b080-c070467166a6
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
20 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
OLANZAPINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui283639

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
82804-067-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED301
82804-067-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED601
82804-067-90Olanzapine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-067-30EA - Each82804-067a6102d1c-4703-48a1-9c58-29cb2a4ab75212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-067OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20240206_024e8e9b-a4fc-4882-b080-c070467166a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283639OLANZapine 20 MG Oral TabletPSN024e8e9b-a4fc-4882-b080-c070467166a61
283639olanzapine 20 MG Oral TabletSCD024e8e9b-a4fc-4882-b080-c070467166a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-067-308280400673030 TABLET, FILM COATED in 1 BOTTLE (82804-067-30) 2024-01-31NoNoCurrent
82804-067-608280400676060 TABLET, FILM COATED in 1 BOTTLE (82804-067-60) 2024-01-31NoNoCurrent
82804-067-908280400679090 TABLET, FILM COATED in 1 BOTTLE (82804-067-90) 2024-01-31NoNoCurrent