FDA.reportPublic FDA data

NDC 59212-700-06 - 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
59212-700
Requested NDC
59212-700-06
Package NDCs from labels
59212-700-06, 59212-700-48, 59212-700-12
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
59212-700-06OrapredODT6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING612
59212-700-12OrapredODT2 in 1 CARTONTABLET, ORALLY DISINTEGRATING212
59212-700-48OrapredODT8 in 1 CARTONTABLET, ORALLY DISINTEGRATING812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-700ORAPRED 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
59212-700-06EA - Each59212-7008a5176aa-7b1a-4800-b754-63604e11789312021-03-02
59212-700-12EA - Each59212-7000604f548-d49f-4f67-a5a9-d4c165362b2b12021-01-08
59212-700-48EA - Each59212-70052c3b564-2960-42ab-91e3-2b0ad7f76dff12014-02-04

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 1 of 48 · 952 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
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEATLANTIC BIOLOGICALS CORP.96de9cad-2fb7-4947-87ae-4db57563a83a2026-09-04Warnings, Adverse reactionsExact identifier
unii: IV021NXA9J
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
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
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
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 All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
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
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals, Inc.93b372f7-b811-4c15-85c4-c6dbac342cb42026-08-18Warnings, Adverse reactionsExact identifier
unii: IV021NXA9J
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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