FDA.reportPublic FDA data

NDC 63561-0122-01 - PredniSONE Tablets, USP, 20 mg

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
63561-0122
Requested NDC
63561-0122-01
Package NDCs from labels
63561-0122-1, 63561-0122-2, 63561-0122-5, 63561-0122-01
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE Tablets USP, 20 mgPD-Rx Pharmaceuticals, Inc.2026-08-21HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets USP, 20 mgPD-Rx Pharmaceuticals, Inc.2026-06-04HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets USP, 20 mgPD-Rx Pharmaceuticals, Inc.2026-03-27HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 20 mg - Bryant Ranch PrepackBryant Ranch Prepack2026-03-11HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 20 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-12-03HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 20 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-12-03HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 20 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-10-03HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 20 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-09-26HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets USP, 5 mg, 10 mg, and 20 mgGranulation Technology, Inc.2025-08-15HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 20 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-05-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0122-1PredniSONE Tablets, USP, 20 mg100 in 1 BOTTLETABLET1003
63561-0122-2PredniSONE Tablets, USP, 20 mg1000 in 1 BOTTLETABLET10003
63561-0122-5PredniSONE Tablets, USP, 20 mg500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0122PREDNISONE TABLETS, USP, 5 MG (PREDNISONE) TABLET PREDNISONE TABLETS, USP, 10 MG (PREDNISONE) TABLET PREDNISONE TABLETS, USP, 20 MG (PREDNISONE) TABLET [GRANULATION TECHNOLOGY, INC.]2Current NDC, 3 package rows20250524_a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63561-0122-1EA - Each63561-0122ccaaaa94-79f0-4d69-ba08-9d0a19e96ce112025-05-14
63561-0122-2EA - Each63561-01228741b9cc-9037-4de7-bcb7-7b9b912be1cf12025-07-08
63561-0122-5EA - Each63561-01223c0bdcab-62ef-4e6d-b721-314effa9c6f812025-09-12

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 42 · 824 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
PrednisonePREDNISONERedpharm Drug5407a00b-1bfb-e37d-e063-6294a90a6c412026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.15230866-f547-47bf-ac7d-19afd6a41e2e2026-06-04Warnings, Adverse reactionsExact identifier
application number: ANDA212629
ndc (package): 72789-509-09
ndc (package): 72789-509-15
ndc (package): 72789-509-06
ndc (package): 72789-509-12
ndc (product): 72789-509
rxcui: 312615
spl id: 536e3e07-924e-b3f6-e063-6394a90a1813
spl set id: 15230866-f547-47bf-ac7d-19afd6a41e2e
unii: VB0R961HZT
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.bb32e309-e3c7-4009-bcd4-d97545b7e9752026-06-04Warnings, Adverse reactionsExact identifier
application number: ANDA212629
rxcui: 198145
unii: VB0R961HZT
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
PrednisonePREDNISONEA-S Medication Solutionsaaaa3460-0239-4203-857f-0ada303c21082026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEBryant Ranch Prepackecc48869-3812-4440-a398-749b280620592026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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