FDA.reportPublic FDA data

PredniSONE Tablets, USP, 20 mg

Product NDC
71335-2737
11-digit product format
713352737
Labeler code
71335
Product ID
71335-2737_312a41b9-2327-405a-b39d-40594fdc4eae
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
71335-2737-0PredniSONE Tablets, USP, 20 mg100 in 1 BOTTLETABLET1001
71335-2737-1PredniSONE Tablets, USP, 20 mg6 in 1 BOTTLETABLET61
71335-2737-2PredniSONE Tablets, USP, 20 mg14 in 1 BOTTLETABLET141
71335-2737-3PredniSONE Tablets, USP, 20 mg5 in 1 BOTTLETABLET51
71335-2737-4PredniSONE Tablets, USP, 20 mg10 in 1 BOTTLETABLET101
71335-2737-5PredniSONE Tablets, USP, 20 mg8 in 1 BOTTLETABLET81
71335-2737-6PredniSONE Tablets, USP, 20 mg7 in 1 BOTTLETABLET71
71335-2737-7PredniSONE Tablets, USP, 20 mg24 in 1 BOTTLETABLET241
71335-2737-8PredniSONE Tablets, USP, 20 mg90 in 1 BOTTLETABLET901
71335-2737-9PredniSONE Tablets, USP, 20 mg12 in 1 BOTTLETABLET121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNbfcc98b8-184e-4db4-8079-de88958c774b1
312615prednisone 20 MG Oral TabletSCDbfcc98b8-184e-4db4-8079-de88958c774b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2737-071335273700100 TABLET in 1 BOTTLE (71335-2737-0) 100 tablet2025-09-26NoNoHistorical
71335-2737-1713352737016 TABLET in 1 BOTTLE (71335-2737-1) 6 tablet2025-09-26NoNoHistorical
71335-2737-27133527370214 TABLET in 1 BOTTLE (71335-2737-2) 14 tablet2025-09-26NoNoHistorical
71335-2737-3713352737035 TABLET in 1 BOTTLE (71335-2737-3) 5 tablet2025-09-26NoNoHistorical
71335-2737-47133527370410 TABLET in 1 BOTTLE (71335-2737-4) 10 tablet2025-09-26NoNoHistorical
71335-2737-5713352737058 TABLET in 1 BOTTLE (71335-2737-5) 8 tablet2025-09-26NoNoHistorical
71335-2737-6713352737067 TABLET in 1 BOTTLE (71335-2737-6) 7 tablet2025-09-26NoNoHistorical
71335-2737-77133527370724 TABLET in 1 BOTTLE (71335-2737-7) 24 tablet2025-09-26NoNoHistorical
71335-2737-87133527370890 TABLET in 1 BOTTLE (71335-2737-8) 90 tablet2025-09-26NoNoHistorical
71335-2737-97133527370912 TABLET in 1 BOTTLE (71335-2737-9) 12 tablet2025-09-26NoNoHistorical