prednisone

Product NDC
70518-4354
11-digit product format
705184354
Labeler code
70518
Product ID
70518-4354_3738d71b-07cf-dfa2-e063-6294a90a7f74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213386
Marketing category
ANDA
Marketing start
2025-06-09
Substance
PREDNISONE
Active strength
10 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
70518-4354-07051843540030 TABLET in 1 BLISTER PACK (70518-4354-0) 30 tablet2025-06-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PredniSONE Tablets, USP (10 mg and 20 mg) Rx onlyREMEDYREPACK INC.2025-06-10HUMAN PRESCRIPTION DRUG LABEL1