FDA.reportPublic FDA data

PREDNISONE

Product NDC
71335-1525
11-digit product format
713351525
Labeler code
71335
Product ID
71335-1525_d3f37948-cf5f-4738-b245-4f8f7975887c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210525
Marketing category
ANDA
Marketing start
2018-12-04
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1525-0PREDNISONE11 in 1 BOTTLETABLET116
71335-1525-1PREDNISONE20 in 1 BOTTLETABLET206
71335-1525-2PREDNISONE30 in 1 BOTTLETABLET306
71335-1525-3PREDNISONE40 in 1 BOTTLETABLET406
71335-1525-4PREDNISONE15 in 1 BOTTLETABLET156
71335-1525-5PREDNISONE10 in 1 BOTTLETABLET106
71335-1525-6PREDNISONE21 in 1 BOTTLETABLET216
71335-1525-7PREDNISONE18 in 1 BOTTLETABLET186
71335-1525-8PREDNISONE12 in 1 BOTTLETABLET126
71335-1525-9PREDNISONE23 in 1 BOTTLETABLET236

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1525-1EA - Each71335-152524558c12-229b-4a8c-9563-16eac0c211ee12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1525PREDNISONE TABLET [BRYANT RANCH PREPACK]6Legacy NDC, 10 package rows20200924_45245428-edbd-448a-970b-4ba17b68496d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN45245428-edbd-448a-970b-4ba17b68496d6
198148predniSONE 50 MG Oral TabletPSN45245428-edbd-448a-970b-4ba17b68496d6
312615prednisone 20 MG Oral TabletSCD45245428-edbd-448a-970b-4ba17b68496d6
198148prednisone 50 MG Oral TabletSCD45245428-edbd-448a-970b-4ba17b68496d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1525-07133515250011 TABLET in 1 BOTTLE (71335-1525-0) 11 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-17133515250120 TABLET in 1 BOTTLE (71335-1525-1) 20 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-27133515250230 TABLET in 1 BOTTLE (71335-1525-2) 30 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-37133515250340 TABLET in 1 BOTTLE (71335-1525-3) 40 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-47133515250415 TABLET in 1 BOTTLE (71335-1525-4) 15 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-57133515250510 TABLET in 1 BOTTLE (71335-1525-5) 10 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-67133515250621 TABLET in 1 BOTTLE (71335-1525-6) 21 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-77133515250718 TABLET in 1 BOTTLE (71335-1525-7) 18 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-87133515250812 TABLET in 1 BOTTLE (71335-1525-8) 12 tablet2018-12-040000-00-00NoNoCurrent
71335-1525-97133515250923 TABLET in 1 BOTTLE (71335-1525-9) 23 tablet2018-12-040000-00-00NoNoCurrent