FDA.reportPublic FDA data

PredniSONE

Product NDC
0054-4728
11-digit product format
000544728
Labeler code
0054
Product ID
0054-4728_523ad364-8d95-4679-9290-446d61f36eb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080352
Marketing category
ANDA
Marketing start
1972-04-21
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198144, 198145, 198146, 198148, 205301, 312615, 312617, 315187

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-4728-252022-08-04C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-4728-312022-08-04C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-4728-252022-07-29C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-4728-312022-07-29C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-4728-25PredniSONE100 in 1 BOTTLE, PLASTICTABLET10024
0054-4728-31PredniSONE1000 in 1 BOTTLE, PLASTICTABLET100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-4728-25EA - Each0054-47282f160156-2281-4b78-a6a4-cb7cdbcbbcf312012-07-24
0054-4728-31EA - Each0054-4728cb7edb06-8f31-4017-b366-a16954e6156612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [PHYSICIANS TOTAL CARE, INC.]13
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
MALTOLINACTIVE INGREDIENT3A9RD92BS4PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.]7
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [UNIT DOSE SERVICES]4
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [UNIT DOSE SERVICES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [UNIT DOSE SERVICES]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [UNIT DOSE SERVICES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [UNIT DOSE SERVICES]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [UNIT DOSE SERVICES]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [UNIT DOSE SERVICES]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [UNIT DOSE SERVICES]4
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [C.O. TRUXTON, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [C.O. TRUXTON, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [C.O. TRUXTON, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [C.O. TRUXTON, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [C.O. TRUXTON, INC.]2
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPREDNISONE TABLET [C.O. TRUXTON, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [C.O. TRUXTON, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [C.O. TRUXTON, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [C.O. TRUXTON, INC.]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4728PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.]23Current NDC, Legacy NDC, 2 package rows20240308_3115aef0-fd50-4ec8-a064-3effb695f3f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNf4500eb6-d24a-4247-83f4-99e73346e32826
312617prednisone 5 MG Oral TabletSCDf4500eb6-d24a-4247-83f4-99e73346e32826
198144predniSONE 1 MG Oral TabletPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
198145predniSONE 10 MG Oral TabletPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
198146predniSONE 2.5 MG Oral TabletPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
312615predniSONE 20 MG Oral TabletPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
205301predniSONE 5 MG in 1 mL Concentrate for Oral SolutionPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
315187predniSONE 5 MG in 5 mL Oral SolutionPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
312617predniSONE 5 MG Oral TabletPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
198148predniSONE 50 MG Oral TabletPSN3115aef0-fd50-4ec8-a064-3effb695f3f224
198144prednisone 1 MG Oral TabletSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
315187prednisone 1 MG/ML Oral SolutionSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
198145prednisone 10 MG Oral TabletSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
198146prednisone 2.5 MG Oral TabletSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
312615prednisone 20 MG Oral TabletSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
312617prednisone 5 MG Oral TabletSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
205301prednisone 5 MG/ML Oral SolutionSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
198148prednisone 50 MG Oral TabletSCD3115aef0-fd50-4ec8-a064-3effb695f3f224
205301prednisone 5 MG per 1 ML Concentrate for Oral SolutionSY3115aef0-fd50-4ec8-a064-3effb695f3f224
315187prednisone 5 MG per 5 ML Oral SolutionSY3115aef0-fd50-4ec8-a064-3effb695f3f224
198144predniSONE 1 MG Oral TabletPSN3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
198145predniSONE 10 MG Oral TabletPSN3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
312615predniSONE 20 MG Oral TabletPSN3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
312617predniSONE 5 MG Oral TabletPSN3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
198148predniSONE 50 MG Oral TabletPSN3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
198144prednisone 1 MG Oral TabletSCD3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
198145prednisone 10 MG Oral TabletSCD3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
312615prednisone 20 MG Oral TabletSCD3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
312617prednisone 5 MG Oral TabletSCD3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
198148prednisone 50 MG Oral TabletSCD3b0fd893-75f6-44e6-9a8b-ec5c2f0a282813
312617predniSONE 5 MG Oral TabletPSNaf861c38-3293-13fe-e053-2995a90a99325
312617predniSONE 5 MG Oral TabletPSNab315be2-8d13-be25-e053-2995a90a51845
312617prednisone 5 MG Oral TabletSCDaf861c38-3293-13fe-e053-2995a90a99325
312617prednisone 5 MG Oral TabletSCDab315be2-8d13-be25-e053-2995a90a51845
312617predniSONE 5 MG Oral TabletPSN9269619e-4fa9-459e-aed8-35d9fde140a54
312617prednisone 5 MG Oral TabletSCD9269619e-4fa9-459e-aed8-35d9fde140a54
312617predniSONE 5 MG Oral TabletPSNd12bf294-3bc9-420c-e053-2a95a90a61a33
312617prednisone 5 MG Oral TabletSCDd12bf294-3bc9-420c-e053-2a95a90a61a33
312615predniSONE 20 MG Oral TabletPSN62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617predniSONE 5 MG Oral TabletPSN2fac670c-88f2-4f19-9538-678b6bfe23f52
312617predniSONE 5 MG Oral TabletPSN96c78907-20dc-9585-e053-2a95a90ac21e2
312617predniSONE 5 MG Oral TabletPSN62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312615prednisone 20 MG Oral TabletSCD62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617prednisone 5 MG Oral TabletSCD96c78907-20dc-9585-e053-2a95a90ac21e2
312617prednisone 5 MG Oral TabletSCD62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617prednisone 5 MG Oral TabletSCD2fac670c-88f2-4f19-9538-678b6bfe23f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4728-2500054472825100 TABLET in 1 BOTTLE, PLASTIC (0054-4728-25) 100 tablet1972-04-210000-00-00NoNoCurrent
0054-4728-31000544728311000 TABLET in 1 BOTTLE, PLASTIC (0054-4728-31) 1000 tablet1972-04-210000-00-00NoNoCurrent