FDA.reportPublic FDA data

PredniSONE Tablets, USP, 20 mg

Product NDC
72789-473
11-digit product format
727890473
Labeler code
72789
Product ID
72789-473_4ecdda4c-7ba6-1a7b-e063-6294a90a7359
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE Tablets, USP, 20 mg
Listing expiration
2027-12-31

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
72789-473-01PredniSONE Tablets, USP, 20 mg100 in 1 BOTTLE, PLASTICTABLET10012
72789-473-04PredniSONE Tablets, USP, 20 mg4 in 1 BOTTLE, PLASTICTABLET412
72789-473-05PredniSONE Tablets, USP, 20 mg5 in 1 BOTTLE, PLASTICTABLET512
72789-473-10PredniSONE Tablets, USP, 20 mg10 in 1 BOTTLE, PLASTICTABLET1012
72789-473-14PredniSONE Tablets, USP, 20 mg14 in 1 BOTTLE, PLASTICTABLET1412
72789-473-18PredniSONE Tablets, USP, 20 mg18 in 1 BOTTLE, PLASTICTABLET1812
72789-473-20PredniSONE Tablets, USP, 20 mg20 in 1 BOTTLE, PLASTICTABLET2012
72789-473-21PredniSONE Tablets, USP, 20 mg21 in 1 BOTTLE, PLASTICTABLET2112
72789-473-25PredniSONE Tablets, USP, 20 mg25 in 1 BOTTLE, PLASTICTABLET2512
72789-473-30PredniSONE Tablets, USP, 20 mg30 in 1 BOTTLE, PLASTICTABLET3012
72789-473-95PredniSONE Tablets, USP, 20 mg1000 in 1 BOTTLE, PLASTICTABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-473-01EA - Each72789-473e2455b4a-aa78-4f40-8cf8-1123f07377f412025-05-14
72789-473-04EA - Each72789-47319a418ff-da71-4dc7-aebb-b5f165479a8512026-01-08
72789-473-14EA - Each72789-4735b2c65c1-c41a-4731-807a-b2e30ac7ab8112026-04-20
72789-473-18EA - Each72789-47385cfba00-1f6a-472d-90b3-ee076b0165e312026-05-22
72789-473-21EA - Each72789-4737c9205a1-96b3-4b96-a478-45a394da46e812025-06-13
72789-473-25EA - Each72789-47328aa09b5-784e-459a-bf19-a9add2eb360912025-06-13
72789-473-30EA - Each72789-47391a8c811-b6a0-4597-bfe2-11110672fa4b12025-07-08
72789-473-95EA - Each72789-4739bf4fcfb-ee09-4e52-8116-c67777123fe912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-473PREDNISONE TABLETS, USP, 20 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.]4Current NDC, 11 package rows20250514_6b360c1f-c862-47ee-a40e-3903c2d6162f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN6b360c1f-c862-47ee-a40e-3903c2d6162f12
312615prednisone 20 MG Oral TabletSCD6b360c1f-c862-47ee-a40e-3903c2d6162f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-473-0172789047301100 TABLET in 1 BOTTLE, PLASTIC (72789-473-01) 100 tablet2025-05-22NoNoCurrent
72789-473-04727890473044 TABLET in 1 BOTTLE, PLASTIC (72789-473-04) 4 tablet2025-12-24NoNoCurrent
72789-473-05727890473055 TABLET in 1 BOTTLE, PLASTIC (72789-473-05) 5 tablet2025-06-09NoNoCurrent
72789-473-107278904731010 TABLET in 1 BOTTLE, PLASTIC (72789-473-10) 10 tablet2025-06-10NoNoCurrent
72789-473-147278904731414 TABLET in 1 BOTTLE, PLASTIC (72789-473-14) 14 tablet2026-03-04NoNoCurrent
72789-473-187278904731818 TABLET in 1 BOTTLE, PLASTIC (72789-473-18) 18 tablet2026-04-06NoNoCurrent
72789-473-207278904732020 TABLET in 1 BOTTLE, PLASTIC (72789-473-20) 20 tablet2025-06-09NoNoCurrent
72789-473-217278904732121 TABLET in 1 BOTTLE, PLASTIC (72789-473-21) 21 tablet2025-05-22NoNoCurrent
72789-473-257278904732525 TABLET in 1 BOTTLE, PLASTIC (72789-473-25) 25 tablet2025-05-22NoNoCurrent
72789-473-307278904733030 TABLET in 1 BOTTLE, PLASTIC (72789-473-30) 30 tablet2025-05-30NoNoCurrent
72789-473-95727890473951000 TABLET in 1 BOTTLE, PLASTIC (72789-473-95) 1000 tablet2025-05-22NoNoCurrent