FDA.reportPublic FDA data

NDC 67877-174-33 - Olanzapine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67877-174
Requested NDC
67877-174-33
Package NDCs from labels
67877-174-32, 67877-174-30, 67877-174-01, 67877-174-10, 67877-174-33, 67877-174-85, 67877-174-35
Manufacturer
Ascend Laboratories, LLC | Alkem Laboratories Limited
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-12-23Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67877-174-012022-10-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-102022-10-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-302022-10-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-322022-10-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-352022-10-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-852022-10-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-012020-01-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-102020-01-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-302020-01-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-322020-01-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-352020-01-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
67877-174-852020-01-31These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-174-01Olanzapine100 in 1 BOTTLETABLET10012
67877-174-10Olanzapine1000 in 1 BOTTLETABLET100012
67877-174-30Olanzapine30 in 1 BOTTLETABLET3012
67877-174-32Olanzapine7 in 1 BOTTLETABLET712
67877-174-33Olanzapine10 in 1 BLISTER PACKTABLET1012
67877-174-35Olanzapine10 in 1 CARTONTABLET1012
67877-174-85Olanzapine3 in 1 CARTONTABLET312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-174OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]9Current NDC, Legacy NDC, 7 package rows20221101_e8626e68-088d-47ff-bf06-489a778815aa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
PECTININACTIVE INGREDIENT89NA02M4RXOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
SHELLACINACTIVE INGREDIENT46N107B71OOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7
TRIACETININACTIVE INGREDIENTXHX3C3X673OLANZAPINE TABLET [ASCEND LABORATORIES, LLC]7

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 149 · 2,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX Antiseptic WipesBZK ANTISEPTIC CLEANING WIPEChangzhou Maokang Medical Products Co., Ltd.5a82d9fb-dff8-1c89-e063-6394a90a32c92026-09-03WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
unii: ND2M416302
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
unii: ND2M416302
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
unii: ND2M416302
Medline Alcohol Swabstick TriplesISOPROPYL ALCOHOLMedline Industries, LPe7759368-97c5-4b10-9bca-c197aeb62e462026-09-01WarningsExact identifier
unii: ND2M416302
70% Isopropyl AlcoholISOPROPYL ALCOHOLUpLift Brands, LLC8ae12375-3a95-475c-9600-17c51a9103f72026-08-31Warnings, Adverse reactionsExact identifier
unii: ND2M416302
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
unii: 89NA02M4RX
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
unii: ND2M416302
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
unii: 89NA02M4RX
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
OlanzapineOLANZAPINEHikma Pharmaceuticals USA Inc.63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d12026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.