FDA.reportPublic FDA data

OLANZAPINE

Product NDC
55150-308
11-digit product format
551500308
Labeler code
55150
Product ID
55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLANZAPINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Eugia US LLC
Application
ANDA210968
Marketing category
ANDA
Marketing start
2020-10-22
Substance
OLANZAPINE
Active strength
10 mg/1
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/1

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
55150-308-01OLANZAPINE1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16
55150-308-01OLANZAPINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
55150-308-10OLANZAPINE10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106
55150-308-10OLANZAPINE1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-308-01EA - Each55150-308d6beb9ab-301a-4fda-b13c-d3350cd4d5ac12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-308OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]4Current NDC, Legacy NDC, 4 package rows20250322_9c745e2e-89d3-44d4-906e-704705c33310.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485968OLANZapine 10 MG InjectionPSN9c745e2e-89d3-44d4-906e-704705c333106
485968olanzapine 10 MG InjectionSCD9c745e2e-89d3-44d4-906e-704705c333106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-308-01551500308011 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2020-10-220000-00-00NoNoCurrent
55150-308-105515003081010 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2020-10-220000-00-00NoNoCurrent