FDA.reportPublic FDA data

PredniSONE Tablets, USP, 20 mg

Product NDC
72162-2486
11-digit product format
721622486
Labeler code
72162
Product ID
72162-2486_34683b0d-a48c-74f4-e063-6294a90a40b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212629
Marketing category
ANDA
Marketing start
2024-03-06
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
72162-2486-0PredniSONE Tablets, USP, 20 mg1000 in 1 BOTTLETABLET10001
72162-2486-1PredniSONE Tablets, USP, 20 mg100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2486-0EA - Each72162-2486963c574e-5dcf-40e0-aaa0-bdf954c4e09212025-06-13
72162-2486-1EA - Each72162-2486dbc378cf-32db-4f6c-bb07-833738a4099b12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2486PREDNISONE TABLETS, USP, 20 MG (PREDNISONE) TABLET [BRYANT RANCH PREPACK]1Current NDC, 2 package rows20250507_48ee895b-dc3a-4f1f-8688-e06c217f449b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN48ee895b-dc3a-4f1f-8688-e06c217f449b1
312615prednisone 20 MG Oral TabletSCD48ee895b-dc3a-4f1f-8688-e06c217f449b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2486-0721622486001000 TABLET in 1 BOTTLE (72162-2486-0) 1000 tablet2025-05-05NoNoHistorical
72162-2486-172162248601100 TABLET in 1 BOTTLE (72162-2486-1) 100 tablet2025-05-05NoNoHistorical