Olanzapine

Product NDC
72843-576
11-digit product format
728430576
Labeler code
72843
Product ID
72843-576_4dd1ba70-4209-9711-e063-6294a90ae979
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
UBI Pharma Inc.
Application
ANDA211072
Marketing category
ANDA
Marketing start
2020-05-08
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
Brand name suffix
Intramuscular
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
72843-576-01OlanzapineIntramuscular2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION25
72843-576-01OlanzapineIntramuscular1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485968OLANZapine 10 MG InjectionPSN6a279fe1-ed99-4a62-b2c7-831961470fa95
485968olanzapine 10 MG InjectionSCD6a279fe1-ed99-4a62-b2c7-831961470fa95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72843-576-01728430576011 VIAL in 1 CARTON (72843-576-01) / 2 mL in 1 VIAL1 vial2020-05-08NoNoHistorical