Prednisone

Product NDC
67046-1448
11-digit product format
670461448
Labeler code
67046
Product ID
67046-1448_2d99223a-8501-7640-e063-6394a90a260a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA040581
Marketing category
ANDA
Marketing start
2025-02-07
Substance
PREDNISONE
Active strength
2.5 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
67046-1448-36704614480330 TABLET in 1 BLISTER PACK (67046-1448-3) 30 tablet2025-02-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx onlyCoupler LLC2025-02-07HUMAN PRESCRIPTION DRUG LABEL1