FDA.reportPublic FDA data

PredniSONE Tablets, USP, 20 mg

Product NDC
71335-2754
11-digit product format
713352754
Labeler code
71335
Product ID
71335-2754_fd21957e-bea4-4025-9058-bcdd33d032ad
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE Tablets, USP, 20 mg
Listing expiration
2026-12-31

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
71335-2754-0PredniSONE Tablets, USP, 20 mg11 in 1 BOTTLETABLET111
71335-2754-1PredniSONE Tablets, USP, 20 mg20 in 1 BOTTLETABLET201
71335-2754-2PredniSONE Tablets, USP, 20 mg30 in 1 BOTTLETABLET301
71335-2754-3PredniSONE Tablets, USP, 20 mg40 in 1 BOTTLETABLET401
71335-2754-4PredniSONE Tablets, USP, 20 mg15 in 1 BOTTLETABLET151
71335-2754-5PredniSONE Tablets, USP, 20 mg10 in 1 BOTTLETABLET101
71335-2754-6PredniSONE Tablets, USP, 20 mg21 in 1 BOTTLETABLET211
71335-2754-7PredniSONE Tablets, USP, 20 mg18 in 1 BOTTLETABLET181
71335-2754-8PredniSONE Tablets, USP, 20 mg12 in 1 BOTTLETABLET121
71335-2754-9PredniSONE Tablets, USP, 20 mg23 in 1 BOTTLETABLET231

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNb42adc18-21cc-4fe0-bf7d-fb76f4cda2151
312615prednisone 20 MG Oral TabletSCDb42adc18-21cc-4fe0-bf7d-fb76f4cda2151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2754-07133527540011 TABLET in 1 BOTTLE (71335-2754-0) 11 tablet2025-10-03NoNoHistorical
71335-2754-17133527540120 TABLET in 1 BOTTLE (71335-2754-1) 20 tablet2025-10-03NoNoHistorical
71335-2754-27133527540230 TABLET in 1 BOTTLE (71335-2754-2) 30 tablet2025-10-03NoNoHistorical
71335-2754-37133527540340 TABLET in 1 BOTTLE (71335-2754-3) 40 tablet2025-10-03NoNoHistorical
71335-2754-47133527540415 TABLET in 1 BOTTLE (71335-2754-4) 15 tablet2025-10-03NoNoHistorical
71335-2754-57133527540510 TABLET in 1 BOTTLE (71335-2754-5) 10 tablet2025-10-03NoNoHistorical
71335-2754-67133527540621 TABLET in 1 BOTTLE (71335-2754-6) 21 tablet2025-10-03NoNoHistorical
71335-2754-77133527540718 TABLET in 1 BOTTLE (71335-2754-7) 18 tablet2025-10-03NoNoHistorical
71335-2754-87133527540812 TABLET in 1 BOTTLE (71335-2754-8) 12 tablet2025-10-03NoNoHistorical
71335-2754-97133527540923 TABLET in 1 BOTTLE (71335-2754-9) 23 tablet2025-10-03NoNoHistorical