FDA.reportPublic FDA data

NDC 59212-702-06 - Orapred ODT

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
59212-702
Requested NDC
59212-702-06
Package NDCs from labels
59212-702-06, 59212-702-48, 59212-702-12
Manufacturer
Advanz Pharma (US) Corp.
Effective date
2025-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Orapred ODT - Advanz Pharma (US) Corp.Advanz Pharma (US) Corp.2025-06-03Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59212-702-06OrapredODT6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING612
59212-702-12OrapredODT2 in 1 CARTONTABLET, ORALLY DISINTEGRATING212
59212-702-48OrapredODT8 in 1 CARTONTABLET, ORALLY DISINTEGRATING812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-702ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [ADVANZ PHARMA (US) CORP.]11Current NDC, Legacy NDC, 3 package rows20250430_1e379543-c4cf-4e72-953b-db15b7f0c2a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-702-06EA - Each59212-702a8ec1556-1c16-4eed-bc92-5d6e951821b612021-03-02
59212-702-12EA - Each59212-702825551d3-467c-41b5-abd9-83da9fc5cd9012021-01-08
59212-702-48EA - Each59212-702297b149f-8117-4d93-95e6-4fbef1de10a312014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONE SODIUM PHOSPHATEACTIVE INGREDIENTIV021NXA9JORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.]2

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 3 of 48 · 952 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PrednisoLONE Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmad1f937e7-fed5-4079-bd52-5d930b34ae9f2026-06-25Warnings, Adverse reactionsExact identifier
unii: IV021NXA9J
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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