FDA.reportPublic FDA data

PredniSONE

Product NDC
43353-657
11-digit product format
433530657
Labeler code
43353
Product ID
43353-657_807590d2-2eea-48f1-b9d3-c4dd0aff2765
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA080352
Marketing category
ANDA
Marketing start
1972-04-21
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-657-602023-01-30C16284748780-1f386c649-c189-0266-e053-dadaa90a7c1aPredniSONE Tablets USP, 5 mg PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-657-60PredniSONE90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-657-60EA - Each43353-657bf3e4250-eded-4e64-bc1d-4a5f16a9d66312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
43353-657PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2Legacy NDC, 1 package rows20191221_2fac670c-88f2-4f19-9538-678b6bfe23f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN2fac670c-88f2-4f19-9538-678b6bfe23f52
312617prednisone 5 MG Oral TabletSCD2fac670c-88f2-4f19-9538-678b6bfe23f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-657-604335306576090 TABLET in 1 BOTTLE, PLASTIC (43353-657-60) 90 tablet2010-08-250000-00-00NoNoCurrent