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 4 of 43 · 847 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
PrednisonePREDNISONEBryant Ranch Prepack6c0376c4-87cf-40dc-b140-a6aac75b64f72026-07-13Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
PrednisonePREDNISONEANI Pharmaceuticals, Inc.f05eb734-07e7-491c-b2e9-aae340e037502026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
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
prednisonePREDNISONEUnit Dose Solutions, Inc.5590d36d-dbe7-1c78-e063-6294a90ad2d42026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC03228706-92b9-43c9-8d73-c73aa124c58d2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
PredniSONEPREDNISONESt. Mary's Medical Park Pharmacy16ee689e-c7a9-3a5a-e063-6394a90a6ea22026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact 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, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
PrednisonePREDNISONESt. Mary's Medical Park Pharmacy1b3ea4cc-5bc6-ae47-e063-6294a90af13d2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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