PredniSONE

Product NDC
67296-1194
11-digit product format
672961194
Labeler code
67296
Product ID
67296-1194_d610062d-3992-dec3-e053-2995a90a9ca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA084283
Marketing category
ANDA
Marketing start
2003-03-14
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
50 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1194-3PredniSONE3 in 1 BOTTLETABLET34
67296-1194-5PredniSONE5 in 1 BOTTLETABLET54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1194PREDNISONE TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 2 package rows20240716_4ecb7106-afbf-01a7-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSN4ecb7106-afbf-01a7-e054-00144ff8d46c4
198148prednisone 50 MG Oral TabletSCD4ecb7106-afbf-01a7-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1194-3672961194033 TABLET in 1 BOTTLE (67296-1194-3) 3 tablet2003-03-140000-00-00NoNoCurrent
67296-1194-5672961194055 TABLET in 1 BOTTLE (67296-1194-5) 5 tablet2003-03-140000-00-00NoNoCurrent