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 8 of 42 · 824 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e2026-03-27Warnings, Adverse reactionsExact identifier
application number: ANDA212629
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.3befbdc5-7d20-41b6-ad80-98e1c6b8caf52026-03-27Warnings, Adverse reactionsExact identifier
application number: ANDA212629
ndc (package): 72789-500-21
ndc (product): 72789-500
rxcui: 312615
spl id: 4e04898e-119a-d5a7-e063-6394a90acef8
spl set id: 3befbdc5-7d20-41b6-ad80-98e1c6b8caf5
unii: VB0R961HZT
PREDNISONEPREDNISONEA-S Medication Solutions53c66f70-58fd-4d4c-b054-e5cefdc0c6372026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.d6df3295-3118-49af-be05-b1fab0d4adaa2026-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA212629
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.14d50f54-410b-45b2-a639-31498ceaf8542026-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA212629
rxcui: 198145
unii: VB0R961HZT
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
PrednisonePREDNISONEA-S Medication Solutionsb5b088b9-8f90-468f-b7a4-a5274aa0aec92026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
Prednisone D/PPREDNISONE D/PDirect_Rx41ade439-59f2-dfd1-e063-6294a90aca0f2026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PREDNISONEPREDNISONEDIRECT RX2a053775-6f6a-455e-b9a8-8b60e6062db32026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
PREDNISONEPREDNISONEA-S Medication Solutionse753e2bc-acca-46eb-888c-ae72fcac6ca42026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEA-S Medication Solutionsa8f6298a-1084-4226-bfd9-a543a26ad2e72026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack852ea185-1bda-4c89-a192-ee0f93cba4282026-03-11Warnings, Adverse reactionsExact identifier
application number: ANDA212629
ndc (package): 71335-2938-1
ndc (package): 71335-2938-2
ndc (product): 71335-2938
rxcui: 312615
spl id: 22e0fdee-6d41-42cd-9370-89c9822d29dc
spl set id: 852ea185-1bda-4c89-a192-ee0f93cba428
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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