FDA.reportPublic FDA data

NDC 48433-321-01 - Prednisone

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
48433-321
Requested NDC
48433-321-01
Package NDCs from labels
48433-321-01, 48433-321-10
Manufacturer
Safecor Health, LLC
Effective date
2011-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prednisone - Safecor Health, LLCSafecor Health, LLC2011-03-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [SAFECOR HEALTH, LLC]3
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Magnesium stearateINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [SAFECOR HEALTH, LLC]3
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TPREDNISONE TABLET [SAFECOR HEALTH, LLC]3

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 14 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), SEROTONIN (HYDROCHLORIDE), OXYTOCINEnergique, Inc.b433c635-e38b-4b3a-89cb-4a72a386ad842024-05-06WarningsExact identifier
unii: LMI26O6933
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
PrednisonePREDNISONEProficient Rx LP94f8ec56-667e-4eda-832d-f2936f12dc362024-05-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63106192-35d5-6989-e053-2991aa0aa7142024-04-25Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.db4a13ff-546d-15b7-e053-2a95a90a6adf2024-04-23Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d22024-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT
MotivationDIOSCOREA VILLOSA, LECITHIN, SEPIA, VIOLA ODORATA, ADRENALINUM, LITHIUM CARBONICUM, THYROIDINUM (BOVINE), PLACENTA TOTALIS SUIS, GUAIACUM, SOLANUM TUBEROSUM, ANTIMONIUM CRUDUM, AURUM SULPHURATUM, BARYTA CARBONICA, CHININUM SULPHURICUM, CONIUM MACULATUM, GRAPHITES, LILIUM TIGRINUM, RHUS VENENATA, SELENIUM METALLICUM, ALUMINADeseret Biologicals, Inc.c2bb0fb2-7ffa-4d16-8fff-b4c3dde966f42024-04-01WarningsExact identifier
unii: LMI26O6933
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: LMI26O6933
prednisonePREDNISONEMedsource Pharmaceuticals131780a0-31f3-6588-e063-6294a90a2f8e2024-03-07Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PredniSONEPREDNISONENuCare Pharmaceuticals,Inc.1289c6d2-2707-baca-e063-6294a90a750d2024-02-29Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions95cf05e5-1446-43f5-8447-c04877a747812024-02-27Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
Lung Large Intestine Meridian OpenerALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHURDeseret Biologicals, Inca5c17770-e1c0-48e7-8947-c0434c22cdab2024-02-21WarningsExact identifier
unii: LMI26O6933
PrednisonePREDNISONEANI Pharmaceuticals, Inc.7335a293-992b-490c-ab8a-66a7ca1eea302024-02-16Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PREDNISONEPREDNISONEAurobindo Pharma Limited7b33767f-a520-4470-8f3f-4e86b38d615a2024-02-16Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PREDNISONEPREDNISONEAurobindo Pharma Limitedb1ac4c92-e1fd-4015-b172-0932790ae0192024-02-16Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63102d75-9b2b-84a9-e053-2a91aa0a317d2024-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions410988ea-456a-454e-932c-fcbdbef04ba92024-01-18Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions44069d49-4cf4-4f1e-9fbd-b496c6ca81a12024-01-18Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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