OLANZAPINE

Product NDC
68462-952
11-digit product format
684620952
Labeler code
68462
Product ID
68462-952_2e709eaf-4116-4ee3-8dff-ace36181d115
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLANZAPINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA220323
Marketing category
ANDA
Marketing start
2026-03-05
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
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-952-10OLANZAPINE2 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,21
68462-952-10OLANZAPINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485968OLANZapine 10 MG InjectionPSN2e709eaf-4116-4ee3-8dff-ace36181d1151
485968olanzapine 10 MG InjectionSCD2e709eaf-4116-4ee3-8dff-ace36181d1151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-952-10684620952101 VIAL in 1 CARTON (68462-952-10) / 2 mL in 1 VIAL1 vial2026-03-05NoNoCurrent