FDA.reportPublic FDA data

NDC 67877-177-33 - 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
67877-177
Requested NDC
67877-177-33
Package NDCs from labels
67877-177-37, 67877-177-30, 67877-177-01, 67877-177-10, 67877-177-33, 67877-177-85, 67877-177-35
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
67877-177-012022-10-31These 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
67877-177-102022-10-31These 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
67877-177-302022-10-31These 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
67877-177-352022-10-31These 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
67877-177-372022-10-31These 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
67877-177-852022-10-31These 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
67877-177-012020-01-31These 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
67877-177-102020-01-31These 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
67877-177-302020-01-31These 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
67877-177-352020-01-31These 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
67877-177-372020-01-31These 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
67877-177-852020-01-31These 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
67877-177-01Olanzapine100 in 1 BOTTLETABLET10012
67877-177-10Olanzapine1000 in 1 BOTTLETABLET100012
67877-177-30Olanzapine30 in 1 BOTTLETABLET3012
67877-177-33Olanzapine10 in 1 BLISTER PACKTABLET1012
67877-177-35Olanzapine10 in 1 CARTONTABLET1012
67877-177-37Olanzapine7 in 1 BOTTLETABLET712
67877-177-85Olanzapine3 in 1 CARTONTABLET312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-177OLANZAPINE 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 1 of 149 · 2,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
unii: ND2M416302
OlanzapineOLANZAPINECoupler LLC5af81f87-5582-aa23-e063-6294a90a1ee82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312078
unii: N7U69T4SZR
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
unii: ND2M416302
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: ND2M416302
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
unii: ND2M416302
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
unii: ND2M416302
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Members MarkISOPROPYL ALCOHOLSams West Incc251ac50-f74f-4a48-e053-2a95a90aac0d2026-09-04WarningsExact identifier
unii: ND2M416302
WalmartISOPROPYL ALCOHOLWalmart, Inc.2f1342ef-1843-40a6-e063-6294a90a577f2026-09-04WarningsExact identifier
unii: ND2M416302
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-09-04WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLSuperValu, Inc.5e6e6d6f-4472-40f1-b0a9-96cee7ef075b2026-09-04WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLFoodhold U.S.A. LLCa94c023c-5313-4940-90a7-b3061a8b90e12026-09-04WarningsExact identifier
unii: ND2M416302
MeijerISOPROPYL ALCOHOLMeijer Distribution Incca008d84-cf51-3703-e053-2a95a90a9bf12026-09-04WarningsExact identifier
unii: ND2M416302
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
unii: ND2M416302
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
unii: ND2M416302
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
unii: ND2M416302
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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