Olanzapine

Product NDC
0781-9105
11-digit product format
007819105
Labeler code
0781
Product ID
0781-9105_e43f350f-4bf5-44ce-b81c-fb96224fd917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Sandoz Inc
Application
ANDA201588
Marketing category
ANDA
Marketing start
2011-10-24
Substance
OLANZAPINE
Active strength
10 mg/2mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui485968

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-9105-72Olanzapine2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION29
0781-9105-72Olanzapine1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-9105OLANZAPINE INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]8Current NDC, Legacy NDC, 2 package rows20250321_c44a96cc-817d-4eb5-a13a-00977f76e666.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485968OLANZapine 10 MG InjectionPSNc44a96cc-817d-4eb5-a13a-00977f76e6669
485968olanzapine 10 MG InjectionSCDc44a96cc-817d-4eb5-a13a-00977f76e6669

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-9105-72007819105721 VIAL in 1 CARTON (0781-9105-72) / 2 mL in 1 VIAL1 vial2011-10-240000-00-00NoNoCurrent