FDA.reportPublic FDA data

NDC 65862-656-10 - 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
65862-656
Requested NDC
65862-656-10
Package NDCs from labels
65862-656-10, 65862-656-03
Manufacturer
Aurobindo Pharma Limited
Effective date
2026-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - Aurobindo Pharma LimitedAurobindo Pharma Limited2026-06-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-656-03Olanzapine03 in 1 CARTONTABLET, ORALLY DISINTEGRATING0316
65862-656-10Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-656OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 2 package rows20250312_4d768cfe-3b20-4127-95b9-b4151b28afcc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-656-03EA - Each65862-65667975bb1-66c9-4977-bdc6-a2c0a785ee5d12015-06-09
65862-656-10EA - Each65862-6564f1a6ef6-972e-4b63-b43c-d147b72debbd12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]3

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 5 of 37 · 722 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.032e589c-47b1-4eb1-9466-8160297b81e92026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINEAurobindo Pharma Limited4d768cfe-3b20-4127-95b9-b4151b28afcc2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203708
ndc (package): 65862-656-03
ndc (package): 65862-658-03
ndc (package): 65862-656-10
ndc (package): 65862-659-03
ndc (package): 65862-657-03
ndc (package): 65862-658-10
ndc (package): 65862-659-10
ndc (package): 65862-657-10
ndc (product): 65862-656
ndc (product): 65862-658
ndc (product): 65862-657
ndc (product): 65862-659
ndc11 (package): 65862065610
rxcui: 312076
rxcui: 351108
rxcui: 351107
rxcui: 314155
spl id: b691262a-e798-4bc7-985c-a047495bfd99
spl set id: 4d768cfe-3b20-4127-95b9-b4151b28afcc
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC52bdaaaf-ab54-99d1-e063-6394a90a521f2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINEBryant Ranch Prepack4e90e30c-78a1-486f-a13c-f1ff798216be2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINECoupler LLC51b508ff-dc55-ff36-e063-6294a90a900f2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
OlanzapineOLANZAPINECoupler LLC51b64b6d-4676-a637-e063-6394a90a450c2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINECoupler LLC518a9400-edb8-6403-e063-6294a90a065d2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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