PredniSONE Tablets, USP, 20 mg

Product NDC
71335-2938
11-digit product format
713352938
Labeler code
71335
Product ID
71335-2938_22e0fdee-6d41-42cd-9370-89c9822d29dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212629
Marketing category
ANDA
Marketing start
2025-05-22
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE Tablets, USP, 20 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2938-1PredniSONE Tablets, USP, 20 mg9 in 1 BOTTLETABLET92
71335-2938-2PredniSONE Tablets, USP, 20 mg19 in 1 BOTTLETABLET192

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN852ea185-1bda-4c89-a192-ee0f93cba4282
312615prednisone 20 MG Oral TabletSCD852ea185-1bda-4c89-a192-ee0f93cba4282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2938-1713352938019 TABLET in 1 BOTTLE (71335-2938-1) 9 tablet2025-10-28NoNoHistorical
71335-2938-27133529380219 TABLET in 1 BOTTLE (71335-2938-2) 19 tablet2025-10-28NoNoHistorical