FDA.reportPublic FDA data

PredniSONE Tablets, USP, 5 mg

Product NDC
71335-2753
11-digit product format
713352753
Labeler code
71335
Product ID
71335-2753_d41fab26-b03f-4bee-a72a-06829cf538d7
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE Tablets, USP, 5 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617

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
71335-2753-0PredniSONE Tablets, USP, 5 mg42 in 1 BOTTLETABLET421
71335-2753-1PredniSONE Tablets, USP, 5 mg30 in 1 BOTTLETABLET301
71335-2753-2PredniSONE Tablets, USP, 5 mg78 in 1 BOTTLETABLET781
71335-2753-3PredniSONE Tablets, USP, 5 mg36 in 1 BOTTLETABLET361
71335-2753-4PredniSONE Tablets, USP, 5 mg21 in 1 BOTTLETABLET211
71335-2753-5PredniSONE Tablets, USP, 5 mg15 in 1 BOTTLETABLET151
71335-2753-6PredniSONE Tablets, USP, 5 mg100 in 1 BOTTLETABLET1001
71335-2753-7PredniSONE Tablets, USP, 5 mg20 in 1 BOTTLETABLET201
71335-2753-8PredniSONE Tablets, USP, 5 mg10 in 1 BOTTLETABLET101
71335-2753-9PredniSONE Tablets, USP, 5 mg90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN419058f7-7f30-41a1-964b-8eaa69290dea1
312617prednisone 5 MG Oral TabletSCD419058f7-7f30-41a1-964b-8eaa69290dea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2753-07133527530042 TABLET in 1 BOTTLE (71335-2753-0) 42 tablet2025-10-03NoNoCurrent
71335-2753-17133527530130 TABLET in 1 BOTTLE (71335-2753-1) 30 tablet2025-10-03NoNoCurrent
71335-2753-27133527530278 TABLET in 1 BOTTLE (71335-2753-2) 78 tablet2025-10-03NoNoCurrent
71335-2753-37133527530336 TABLET in 1 BOTTLE (71335-2753-3) 36 tablet2025-10-03NoNoCurrent
71335-2753-47133527530421 TABLET in 1 BOTTLE (71335-2753-4) 21 tablet2025-10-03NoNoCurrent
71335-2753-57133527530515 TABLET in 1 BOTTLE (71335-2753-5) 15 tablet2025-10-03NoNoCurrent
71335-2753-671335275306100 TABLET in 1 BOTTLE (71335-2753-6) 100 tablet2025-10-03NoNoCurrent
71335-2753-77133527530720 TABLET in 1 BOTTLE (71335-2753-7) 20 tablet2025-10-03NoNoCurrent
71335-2753-87133527530810 TABLET in 1 BOTTLE (71335-2753-8) 10 tablet2025-10-03NoNoCurrent
71335-2753-97133527530990 TABLET in 1 BOTTLE (71335-2753-9) 90 tablet2025-10-03NoNoCurrent