FDA.reportPublic FDA data

Olanzapine

Product NDC
60505-3111
11-digit product format
605053111
Labeler code
60505
Product ID
60505-3111_2dd39227-59ef-df97-a57e-d5a013dc132f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA090798
Marketing category
ANDA
Marketing start
2012-04-23
Substance
OLANZAPINE
Active strength
5 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
OLANZAPINE5 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
60505-3111-0Olanzapine10 in 1 CARTONTABLET, FILM COATED1013
60505-3111-0Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED1013
60505-3111-3Olanzapine30 in 1 BOTTLETABLET, FILM COATED3013
60505-3111-8Olanzapine1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3111-0EA - Each60505-3111173c5f9e-fd12-4613-b2a1-a64e1c31624812012-07-24
60505-3111-3EA - Each60505-3111c15d4fde-8109-4a03-811b-3121857eadc612012-07-24
60505-3111-8EA - Each60505-31111e45cee3-df90-4ece-8851-96565b2cd43912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Fd&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTOLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Hypromellose 2910 (6 Mpa.S)INACTIVE INGREDIENT0WZ8WG20P6OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Polyethylene Glycol 1000INACTIVE INGREDIENTU076Q6Q621OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [APOTEX CORP.]2
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3111OLANZAPINE TABLET, FILM COATED [APOTEX CORP.]12Current NDC, Legacy NDC, 4 package rows20250411_3347d1c8-04c9-5ce1-8cda-b38e0412b709.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSNe830f488-c689-40f6-9351-f9c7454ff1ea21
312078olanzapine 5 MG Oral TabletSCDe830f488-c689-40f6-9351-f9c7454ff1ea21
314154OLANZapine 10 MG Oral TabletPSN3347d1c8-04c9-5ce1-8cda-b38e0412b70913
312077OLANZapine 15 MG Oral TabletPSN3347d1c8-04c9-5ce1-8cda-b38e0412b70913
200034OLANZapine 2.5 MG Oral TabletPSN3347d1c8-04c9-5ce1-8cda-b38e0412b70913
283639OLANZapine 20 MG Oral TabletPSN3347d1c8-04c9-5ce1-8cda-b38e0412b70913
312078OLANZapine 5 MG Oral TabletPSN3347d1c8-04c9-5ce1-8cda-b38e0412b70913
312079OLANZapine 7.5 MG Oral TabletPSN3347d1c8-04c9-5ce1-8cda-b38e0412b70913
314154olanzapine 10 MG Oral TabletSCD3347d1c8-04c9-5ce1-8cda-b38e0412b70913
312077olanzapine 15 MG Oral TabletSCD3347d1c8-04c9-5ce1-8cda-b38e0412b70913
200034olanzapine 2.5 MG Oral TabletSCD3347d1c8-04c9-5ce1-8cda-b38e0412b70913
283639olanzapine 20 MG Oral TabletSCD3347d1c8-04c9-5ce1-8cda-b38e0412b70913
312078olanzapine 5 MG Oral TabletSCD3347d1c8-04c9-5ce1-8cda-b38e0412b70913
312079olanzapine 7.5 MG Oral TabletSCD3347d1c8-04c9-5ce1-8cda-b38e0412b70913
314154OLANZapine 10 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312077OLANZapine 15 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
200034OLANZapine 2.5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
283639OLANZapine 20 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312078OLANZapine 5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312079OLANZapine 7.5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
314154olanzapine 10 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312077olanzapine 15 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
200034olanzapine 2.5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
283639olanzapine 20 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312078olanzapine 5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312079olanzapine 7.5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
314154OLANZapine 10 MG Oral TabletPSNf8bee685-7187-4edb-8865-07128035454e7
312078OLANZapine 5 MG Oral TabletPSNf8bee685-7187-4edb-8865-07128035454e7
314154olanzapine 10 MG Oral TabletSCDf8bee685-7187-4edb-8865-07128035454e7
312078olanzapine 5 MG Oral TabletSCDf8bee685-7187-4edb-8865-07128035454e7
312078OLANZapine 5 MG Oral TabletPSNc26391b1-fc43-4e9e-be05-0c47ab6359395
312078olanzapine 5 MG Oral TabletSCDc26391b1-fc43-4e9e-be05-0c47ab6359395
312078OLANZapine 5 MG Oral TabletPSN7772a4c2-1fb1-412b-9e3b-ef3d693517a23
312078olanzapine 5 MG Oral TabletSCD7772a4c2-1fb1-412b-9e3b-ef3d693517a23
312077OLANZapine 15 MG Oral TabletPSN5a1dc228-b757-5f2b-e053-2991aa0adccc1
312078OLANZapine 5 MG Oral TabletPSN5a1dc228-b757-5f2b-e053-2991aa0adccc1
312078OLANZapine 5 MG Oral TabletPSN1866a03c-eac9-44a1-8f33-7dc6e8a8c06a1
312077olanzapine 15 MG Oral TabletSCD5a1dc228-b757-5f2b-e053-2991aa0adccc1
312078olanzapine 5 MG Oral TabletSCD5a1dc228-b757-5f2b-e053-2991aa0adccc1
312078olanzapine 5 MG Oral TabletSCD1866a03c-eac9-44a1-8f33-7dc6e8a8c06a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3111-06050531110010 BLISTER PACK in 1 CARTON (60505-3111-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-04-230000-00-00NoNoCurrent
60505-3111-36050531110330 TABLET, FILM COATED in 1 BOTTLE (60505-3111-3) 2012-04-230000-00-00NoNoCurrent
60505-3111-8605053111081000 TABLET, FILM COATED in 1 BOTTLE (60505-3111-8) 2012-04-230000-00-00NoNoCurrent