FDA.reportPublic FDA data

Olanzapine

Product NDC
60505-3110
11-digit product format
605053110
Labeler code
60505
Product ID
60505-3110_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
2.5 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
OLANZAPINE2.5 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
60505-3110-0Olanzapine10 in 1 CARTONTABLET, FILM COATED1013
60505-3110-0Olanzapine10 in 1 BLISTER PACKTABLET, FILM COATED1013
60505-3110-3Olanzapine30 in 1 BOTTLETABLET, FILM COATED3013
60505-3110-8Olanzapine1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3110-0EA - Each60505-31101d062835-9f6f-4dd6-9c91-4e531e51884712012-07-24
60505-3110-3EA - Each60505-311088fd2249-0573-4c4b-ac9b-64f3c3e6c38112012-07-24
60505-3110-8EA - Each60505-3110d68c2cb3-756d-4b02-9947-75f4be699ba712013-02-13

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 [PROFICIENT RX LP]1
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]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
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3110OLANZAPINE 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
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
200034OLANZapine 2.5 MG Oral TabletPSN032e589c-47b1-4eb1-9466-8160297b81e96
200034olanzapine 2.5 MG Oral TabletSCD032e589c-47b1-4eb1-9466-8160297b81e96
314154OLANZapine 10 MG Oral TabletPSNe40d54bf-7334-4418-8a87-ff85941adec14
200034OLANZapine 2.5 MG Oral TabletPSNe40d54bf-7334-4418-8a87-ff85941adec14
314154olanzapine 10 MG Oral TabletSCDe40d54bf-7334-4418-8a87-ff85941adec14
200034olanzapine 2.5 MG Oral TabletSCDe40d54bf-7334-4418-8a87-ff85941adec14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3110-06050531100010 BLISTER PACK in 1 CARTON (60505-3110-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-04-230000-00-00NoNoCurrent
60505-3110-36050531100330 TABLET, FILM COATED in 1 BOTTLE (60505-3110-3) 2012-04-230000-00-00NoNoCurrent
60505-3110-8605053110081000 TABLET, FILM COATED in 1 BOTTLE (60505-3110-8) 2012-04-230000-00-00NoNoCurrent