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 11 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONEPREDNISONEAdvanced Rx of Tennessee, LLC2e62cf2e-dcbe-c15e-e063-6294a90a81682025-02-17Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PREDNISONEPREDNISONEAdvanced Rx of Tennessee, LLC2e62cf2e-dcbf-c15e-e063-6294a90a81682025-02-17Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PredniSONEPREDNISONEAdvanced Rx of Tennessee, LLC2e630aa1-eccd-f5eb-e063-6294a90a47452025-02-17Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONECoupler LLC2d99223a-853a-7640-e063-6394a90a260a2025-02-07Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: LMI26O6933
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: LMI26O6933
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: LMI26O6933
Bestmade Natural Products BM40ALUMINAD7, CAUSTICUMD8, GELSEMIUMD3, MOSCHUSD14, PLUMBUMD9, SECALE CORND4, ZINCUM ACETD9Bestmade Natural Productsef43f183-1be9-4c7e-e053-2a95a90a4b062025-01-23WarningsExact identifier
unii: LMI26O6933
PREDNISONEPREDNISONEPreferred Pharmaceuticals Inc.94d82acb-ff31-492f-bd51-b23e15d881d62025-01-23Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEDirect_Rxfd8eb82e-52df-c368-e053-6294a90ac6b02025-01-22Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
Bestmade Natural Products BM6AGRIMONIAD6, ALUMINAD12, HYDRASTISD4, KALI BICHD6, PULSATILLAD5, SEPIAD4Bestmade Natural Productsec034f53-5577-5985-e053-2995a90a67292025-01-22WarningsExact identifier
unii: LMI26O6933
Bestmade Natural Products BM21ALUMINAD5, BRYONIAD5, COLOCYNTHISD6, GRAPHITED10, HYDRASTISD3, LYCOPODIUMD4, MAG MURD12, NUX VOMICAD5,OPIUMD30, PLUMBUMD7Bestmade Natural Productsedc29044-5fae-7916-e053-2995a90a59882025-01-22WarningsExact identifier
unii: LMI26O6933
D-37ALUMINUM OXIDE, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, AND SULFURDNA Labs, Inc.3b408532-b84b-4398-ab8d-64d5a9c8d0922025-01-13WarningsExact identifier
unii: LMI26O6933
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: LMI26O6933
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: LMI26O6933
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf863b9e-964b-3b1e-e053-2995a90ab93a2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf861c38-3293-13fe-e053-2995a90a99322024-12-31Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbf833-b929-8c85-e053-2995a90a58962024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCe1e7d14b-80b2-f57e-e053-2995a90af1122024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbff9f-610f-7782-e053-2a95a90a71c12024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040362
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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