FDA.reportPublic FDA data

PredniSONE Tablets, USP, 20 mg

Product NDC
72789-509
11-digit product format
727890509
Labeler code
72789
Product ID
72789-509_3ac67c26-d570-32a9-e063-6294a90a1048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72789-509-06PredniSONE Tablets, USP, 20 mg6 in 1 BOTTLE, PLASTICTABLET66
72789-509-09PredniSONE Tablets, USP, 20 mg9 in 1 BOTTLE, PLASTICTABLET96
72789-509-12PredniSONE Tablets, USP, 20 mg12 in 1 BOTTLE, PLASTICTABLET126
72789-509-15PredniSONE Tablets, USP, 20 mg15 in 1 BOTTLE, PLASTICTABLET156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-509-06EA - Each72789-5093106d31e-bc96-42fd-b494-713ed7ca29bb12025-08-11
72789-509-09EA - Each72789-5097338747d-fab0-4b2f-aa99-ef2d606ef4c212025-07-08
72789-509-12EA - Each72789-509c426095f-ea99-4faf-b4fc-74c4e472b64612025-08-11
72789-509-15EA - Each72789-509a60320bb-f889-4d2d-b349-174eb029f90a12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-509PREDNISONE TABLETS, USP, 20 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20250529_15230866-f547-47bf-ac7d-19afd6a41e2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN15230866-f547-47bf-ac7d-19afd6a41e2e6
312615prednisone 20 MG Oral TabletSCD15230866-f547-47bf-ac7d-19afd6a41e2e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-509-06727890509066 TABLET in 1 BOTTLE, PLASTIC (72789-509-06) 6 tablet2025-06-20NoNoCurrent
72789-509-09727890509099 TABLET in 1 BOTTLE, PLASTIC (72789-509-09) 9 tablet2025-05-27NoNoCurrent
72789-509-127278905091212 TABLET in 1 BOTTLE, PLASTIC (72789-509-12) 12 tablet2025-07-09NoNoCurrent
72789-509-157278905091515 TABLET in 1 BOTTLE, PLASTIC (72789-509-15) 15 tablet2025-05-22NoNoCurrent