FDA.reportPublic FDA data

NDC 63561-0120-02 - PredniSONE Tablets, USP, 5 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
63561-0120
Requested NDC
63561-0120-02
Package NDCs from labels
63561-0120-1, 63561-0120-2, 63561-0120-5, 63561-0120-02
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE Tablets USP, 5 mgPD-Rx Pharmaceuticals, Inc.2026-03-27HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets USP, 5 mgPD-Rx Pharmaceuticals, Inc.2026-03-25HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 5 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-12-03HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 5 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-12-03HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 5 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-10-20HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets, USP, 5 mg - Bryant Ranch PrepackBryant Ranch Prepack2025-10-03HUMAN PRESCRIPTION DRUG LABEL
PredniSONE Tablets USP, 5 mg, 10 mg, and 20 mgGranulation Technology, Inc.2025-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0120-1PredniSONE Tablets, USP, 5 mg100 in 1 BOTTLETABLET1003
63561-0120-2PredniSONE Tablets, USP, 5 mg1000 in 1 BOTTLETABLET10003
63561-0120-5PredniSONE Tablets, USP, 5 mg500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0120PREDNISONE 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
63561-0120-1EA - Each63561-0120541baf4a-bc07-41ed-b02a-82cc88c8131d12025-07-08
63561-0120-2EA - Each63561-01204f21dfd0-2b74-490b-98d8-abfecb7047b712025-07-08
63561-0120-5EA - Each63561-012022880506-0669-48ed-baa8-a5f3487239c612025-09-12

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 1 of 43 · 855 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
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.4750028a-30ad-420a-8e6b-06dc2429d4332026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack0062fcc7-aa08-4990-9d33-d798725907f12026-09-08Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
PredniSONEPREDNISONEREMEDYREPACK INC.7db793b4-5768-4e9a-a47b-1ebbfed740012026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEREMEDYREPACK INC.0993b354-d936-472b-bafc-114f0f81bfb02026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONEREMEDYREPACK INC.94715919-70bd-46c9-95fc-e151adf39cf92026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
prednisonePREDNISONEREMEDYREPACK INC.23b12d22-97d6-426e-bf9c-dd6c2ff773702026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
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
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
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.6b360c1f-c862-47ee-a40e-3903c2d6162f2026-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA212629
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONEPreferred Pharmaceuticals Inc.02158832-550b-4855-a5c5-6abbf13ed6f02026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepackc60a07f9-ed9f-4434-a69d-2e2fea4843fd2026-08-20Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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