FDA.reportPublic FDA data

NDC 59746-306-12 - 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
59746-306
Requested NDC
59746-306-12
Package NDCs from labels
59746-306-12, 59746-306-32
Manufacturer
Jubilant Cadista Pharmacuticals Inc. | Jubilant Generics Limited
Effective date
2025-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Olanzapine - Jubilant Cadista Pharmacuticals Inc. | Jubilant Generics LimitedJubilant Cadista Pharmacuticals Inc. | Jubilant Generics Limited2025-03-27Human Prescription Drug Label
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-306-322024-12-11C16284748780-1f386c649-9a39-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS. OLANZAPINE orally disintegrating tablets for Oral use Initial U.S. Approval: 1996
59746-306-322023-01-30C16284748780-1f386c649-9a39-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLANZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for OLANZAPINE ORALLY DISINTEGRATING TABLETS. OLANZAPINE orally disintegrating tablets for Oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-306-12Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1017
59746-306-32Olanzapine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING317

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-306OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20250424_028aa88e-fa50-7aa8-cc0b-97c0c9a0357c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-306-12EA - Each59746-3063a0a51b0-942b-44a2-bf5d-602035ec5e7c12013-03-03
59746-306-32EA - Each59746-306fe987b96-c634-4ebc-89a0-e5e7c35cc40312013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OlanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
OlanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
AspartameINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Hydroxypropyl Cellulose, Low SubstitutedINACTIVE INGREDIENT2165RE0K14OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
MannitolINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]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 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINECoupler LLC5af81f87-5582-aa23-e063-6294a90a1ee82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINEHikma Pharmaceuticals USA Inc.63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d12026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
OlanzapineOLANZAPINEREMEDYREPACK INC.c47ee16f-5a86-49f2-8d85-5f49a6c8d91e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N7U69T4SZR
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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