prednisone

Product NDC
0615-8441
11-digit product format
006158441
Labeler code
0615
Product ID
0615-8441_d607202d-61e1-4a93-8456-04833ad570ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA213386
Marketing category
ANDA
Marketing start
2020-06-24
Substance
PREDNISONE
Active strength
20 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
0615-8441-00006158441005 TABLET in 1 BLISTER PACK (0615-8441-00) 5 tablet2024-07-05NoNoHistorical
0615-8441-100061584411010 TABLET in 1 BLISTER PACK (0615-8441-10) 10 tablet2023-08-07NoNoHistorical
0615-8441-390061584413930 TABLET in 1 BLISTER PACK (0615-8441-39) 30 tablet2022-11-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PredniSONE Tablets, USP (10 mg and 20 mg) Rx onlyNCS HealthCare of KY, LLC dba Vangard Labs2024-08-12HUMAN PRESCRIPTION DRUG LABEL5