PredniSONE Tablets, USP, 5 mg

Product NDC
72162-2484
11-digit product format
721622484
Labeler code
72162
Product ID
72162-2484_39778ac0-2eab-4920-ace5-6ac9613f9ab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212629
Marketing category
ANDA
Marketing start
2024-03-06
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VB0R961HZTPREDNISONE53-03-2PREDNISONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2484-0721622484001000 TABLET in 1 BOTTLE (72162-2484-0) 1000 tablet2025-05-05NoNoHistorical
72162-2484-172162248401100 TABLET in 1 BOTTLE (72162-2484-1) 100 tablet2025-05-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PredniSONE Tablets USP, 5 mg, 10 mg, and 20 mgBryant Ranch Prepack2025-10-20HUMAN PRESCRIPTION DRUG LABEL2
PredniSONE Tablets USP, 5 mg, 10 mg, and 20 mgBryant Ranch Prepack2025-05-05HUMAN PRESCRIPTION DRUG LABEL1