Olanzapine

Product NDC
72603-158
11-digit product format
726030158
Labeler code
72603
Product ID
72603-158_bfaf4fef-69a8-40e1-b995-899044ad4a39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
15 mg/1
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
OLANZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 283639, 312077, 312078, 312079, 314154

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
72603-158-01Olanzapine30 in 1 BOTTLETABLET, FILM COATED302
72603-158-02Olanzapine1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-158-01EA - Each72603-158605b69ac-2a0c-497f-a2d9-8c3df2b5eb6612024-05-16
72603-158-02EA - Each72603-15838ae6f1a-a549-4452-a718-3175c33684dd12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-158OLANZAPINE TABLET, FILM COATED [NORTHSTAR RXLLC]2Current NDC, 2 package rows20240711_ea3259d5-36ee-4ac9-b849-9625626e2187.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNea3259d5-36ee-4ac9-b849-9625626e21872
312077OLANZapine 15 MG Oral TabletPSNea3259d5-36ee-4ac9-b849-9625626e21872
200034OLANZapine 2.5 MG Oral TabletPSNea3259d5-36ee-4ac9-b849-9625626e21872
283639OLANZapine 20 MG Oral TabletPSNea3259d5-36ee-4ac9-b849-9625626e21872
312078OLANZapine 5 MG Oral TabletPSNea3259d5-36ee-4ac9-b849-9625626e21872
312079OLANZapine 7.5 MG Oral TabletPSNea3259d5-36ee-4ac9-b849-9625626e21872
314154olanzapine 10 MG Oral TabletSCDea3259d5-36ee-4ac9-b849-9625626e21872
312077olanzapine 15 MG Oral TabletSCDea3259d5-36ee-4ac9-b849-9625626e21872
200034olanzapine 2.5 MG Oral TabletSCDea3259d5-36ee-4ac9-b849-9625626e21872
283639olanzapine 20 MG Oral TabletSCDea3259d5-36ee-4ac9-b849-9625626e21872
312078olanzapine 5 MG Oral TabletSCDea3259d5-36ee-4ac9-b849-9625626e21872
312079olanzapine 7.5 MG Oral TabletSCDea3259d5-36ee-4ac9-b849-9625626e21872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-158-017260301580130 TABLET, FILM COATED in 1 BOTTLE (72603-158-01) 2023-07-05NoNoCurrent
72603-158-02726030158021000 TABLET, FILM COATED in 1 BOTTLE (72603-158-02) 2023-07-05NoNoCurrent