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 7 of 46 · 920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: ETJ7Z6XBU4
LymphoplexMYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEABioActive Nutritional, Inc.624f35db-291e-4e7f-a2c9-ae319717157a2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Equisetum SiliceaEQUISETUM SILICEAUriel Pharmacy Inc.e88b820b-4a07-42e2-8fe2-b30729e91a8c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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