FDA.reportPublic FDA data

PredniSONE

Product NDC
0463-6155
11-digit product format
004636155
Labeler code
0463
Product ID
0463-6155_7f7b221e-0c33-4295-8d8e-cec1cda84c59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
C.O. Truxton, 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
E
Listing certified through
2018-12-31
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
0463-6155-102021-01-29C16284748780-19855e2a2-38a6-60a7-e053-dbdaa90a05bdPredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 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
0463-6155-10PredniSONE1000 in 1 BOTTLE, PLASTICTABLET10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0463-6155PREDNISONE TABLET [C.O. TRUXTON, INC.]2Legacy NDC, 1 package rows20140605_62c77974-61d4-4fe6-a6e4-0a7a1bc86e76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617predniSONE 5 MG Oral TabletPSN62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312615prednisone 20 MG Oral TabletSCD62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617prednisone 5 MG Oral TabletSCD62c77974-61d4-4fe6-a6e4-0a7a1bc86e762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0463-6155-10004636155101000 in 1 BOTTLE, PLASTICHistorical