FDA.reportPublic FDA data

OLANZAPINE

Product NDC
13668-089
11-digit product format
136680089
Labeler code
13668
Product ID
13668-089_1a64829a-2434-4c8d-8e58-9b28758e4b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLANZAPINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091415
Marketing category
ANDA
Marketing start
2011-10-25
Substance
OLANZAPINE
Active strength
15 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
OLANZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 283639, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-089-05OLANZAPINE500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50019
13668-089-30OLANZAPINE30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3019
13668-089-90OLANZAPINE90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-089-30EA - Each13668-089ea4929b6-2947-49d2-88b0-4c2f41af532112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-089OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 3 package rows20250305_2cb1bebe-0ced-46d8-bf21-c28a9acc4a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314154OLANZapine 10 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351107OLANZapine 15 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312077OLANZapine 15 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
200034OLANZapine 2.5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351108OLANZapine 20 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
283639OLANZapine 20 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314155OLANZapine 5 MG Disintegrating Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312078OLANZapine 5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312079OLANZapine 7.5 MG Oral TabletPSN2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312076olanzapine 10 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314154olanzapine 10 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351107olanzapine 15 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312077olanzapine 15 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
200034olanzapine 2.5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
351108olanzapine 20 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
283639olanzapine 20 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
314155olanzapine 5 MG Disintegrating Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312078olanzapine 5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519
312079olanzapine 7.5 MG Oral TabletSCD2cb1bebe-0ced-46d8-bf21-c28a9acc4a1519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-089-0513668008905500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-05) 2011-10-250000-00-00NoNoCurrent
13668-089-301366800893030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-30) 2011-10-250000-00-00NoNoCurrent
13668-089-7413668008974100 TABLET, ORALLY DISINTEGRATING in 1 CARTON (13668-089-74) 2011-10-250000-00-00NoNoCurrent
13668-089-901366800899090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-089-90) 2011-10-250000-00-00NoNoCurrent