Prednisone

Product NDC
76420-069
11-digit product format
764200069
Labeler code
76420
Product ID
76420-069_ade999a8-168a-32d1-e053-2a95a90ac173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
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
76420-069-107642000691010 TABLET in 1 BOTTLE (76420-069-10) 10 tablet2020-08-28NoNoHistorical
76420-069-157642000691515 TABLET in 1 BOTTLE (76420-069-15) 15 tablet2020-08-28NoNoHistorical
76420-069-207642000692020 TABLET in 1 BOTTLE (76420-069-20) 20 tablet2020-08-28NoNoHistorical
76420-069-217642000692121 TABLET in 1 BOTTLE (76420-069-21) 21 tablet2020-08-28NoNoHistorical
76420-069-307642000693030 TABLET in 1 BOTTLE (76420-069-30) 30 tablet2020-08-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PredniSONE Tablets, USP Rx onlyAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2020-08-28HUMAN PRESCRIPTION DRUG LABEL1