PredniSONE

Product NDC
71610-641
11-digit product format
716100641
Labeler code
71610
Product ID
71610-641_f649b29f-331d-4208-b878-16e103986fbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA080352
Marketing category
ANDA
Marketing start
1982-01-01
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-641-60EA - Each71610-6418071ebb2-ff25-4c85-b6d3-e701d7f47b1012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-641PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20220329_3e44e294-1d67-4788-ae07-5a2152d23839.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-641-607161006416090 TABLET in 1 BOTTLE, PLASTIC (71610-641-60) 90 tablet2022-03-240000-00-00NoNoCurrent