PREDNISONE

Product NDC
71335-2356
11-digit product format
713352356
Labeler code
71335
Product ID
71335-2356_2c190497-d792-4aec-a8c0-2a40d5b09c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215672
Marketing category
ANDA
Marketing start
2022-03-28
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

openFDA Listing Details

Product ID
71335-2356_2c190497-d792-4aec-a8c0-2a40d5b09c38
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
PREDNISONE
Generic name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Marketing start
2022-03-28
Marketing category
ANDA
Application number
ANDA215672
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
PREDNISONE2.5 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiVB0R961HZT
Rxcui198146
Spl Set Id29c96865-48be-4898-81b7-a6fc9623d3b9
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VB0R961HZTPREDNISONE53-03-2PREDNISONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2356-17133523560130 TABLET in 1 BOTTLE (71335-2356-1) 30 tablet2024-05-28NoNoCurrent
71335-2356-27133523560290 TABLET in 1 BOTTLE (71335-2356-2) 90 tablet2024-05-28NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prednisone Tablets, USP Rx onlyBryant Ranch Prepack2024-05-28HUMAN PRESCRIPTION DRUG LABEL1