FDA.reportPublic FDA data

PredniSONE

Product NDC
0054-3722
11-digit product format
000543722
Labeler code
0054
Product ID
0054-3722_523ad364-8d95-4679-9290-446d61f36eb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088703
Marketing category
ANDA
Marketing start
1984-11-08
Substance
PREDNISONE
Active strength
5 mg/5mL
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/5mL

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-3722-502022-08-04C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-3722-632022-08-04C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-3722-502022-07-29C16284748780-1e4f33bdf-a799-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE Intensol ™ Oral Solution (Concentrate)
0054-3722-632022-07-29C16284748780-1e4f33bdf-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
0054-3722-50PredniSONE120 mL in 1 BOTTLESOLUTION12024
0054-3722-63PredniSONE500 mL in 1 BOTTLESOLUTION50024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3722-50ML - Milliliter0054-3722b14dddc9-b86a-4780-be62-fae061a050d812012-07-24
0054-3722-63ML - Milliliter0054-3722aa107a7f-f131-423c-a617-cf636b8f1e0212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3722PREDNISONE 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
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
315187predniSONE 5 MG in 5 mL Oral SolutionPSN07be390e-ef1e-4bf9-a9da-4338b5f6cfa55
315187prednisone 1 MG/ML Oral SolutionSCD07be390e-ef1e-4bf9-a9da-4338b5f6cfa55
315187prednisone 5 MG per 5 ML Oral SolutionSY07be390e-ef1e-4bf9-a9da-4338b5f6cfa55
205301predniSONE 5 MG in 1 mL Concentrate for Oral SolutionPSN5b46fc91-dc0a-4049-a767-5efcb1839eea2
205301prednisone 5 MG/ML Oral SolutionSCD5b46fc91-dc0a-4049-a767-5efcb1839eea2
205301prednisone 5 MG per 1 ML Concentrate for Oral SolutionSY5b46fc91-dc0a-4049-a767-5efcb1839eea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3722-5000054372250120 mL in 1 BOTTLE (0054-3722-50) 120 ml1996-12-130000-00-00NoNoCurrent
0054-3722-6300054372263500 mL in 1 BOTTLE (0054-3722-63) 500 ml1984-11-080000-00-00NoNoCurrent