Olanzapine

Product NDC
72603-181
11-digit product format
726030181
Labeler code
72603
Product ID
72603-181_075ca296-d5cc-1898-e063-6394a90acd13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
NorthStar RxLLC
Application
ANDA217466
Marketing category
ANDA
Marketing start
2023-10-16
Substance
OLANZAPINE
Active strength
10 mg/2mL
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/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
72603-181-01Olanzapine2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION21
72603-181-01Olanzapine1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-181-01EA - Each72603-1815956a19e-3ffc-4328-9f9d-481bdc0e408712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-181OLANZAPINE (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20231016_f4e41c2c-d32d-40c2-8afb-b6df998ba6b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485968OLANZapine 10 MG InjectionPSNf4e41c2c-d32d-40c2-8afb-b6df998ba6b01
485968olanzapine 10 MG InjectionSCDf4e41c2c-d32d-40c2-8afb-b6df998ba6b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-181-01726030181011 VIAL in 1 CARTON (72603-181-01) / 2 mL in 1 VIAL1 vial2023-10-16NoNoCurrent