FDA.reportPublic FDA data

Prednisone

Product NDC
72789-393
11-digit product format
727890393
Labeler code
72789
Product ID
72789-393_2e81270b-4e47-3565-e063-6294a90a72af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA211575
Marketing category
ANDA
Marketing start
2019-11-15
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
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
72789-393-02Prednisone2 in 1 BOTTLE, PLASTICTABLET217
72789-393-05Prednisone5 in 1 BOTTLE, PLASTICTABLET517
72789-393-06Prednisone6 in 1 BOTTLE, PLASTICTABLET617
72789-393-09Prednisone9 in 1 BOTTLE, PLASTICTABLET917
72789-393-10Prednisone10 in 1 BOTTLE, PLASTICTABLET1017
72789-393-12Prednisone12 in 1 BOTTLE, PLASTICTABLET1217
72789-393-14Prednisone14 in 1 BOTTLE, PLASTICTABLET1417
72789-393-15Prednisone15 in 1 BOTTLE, PLASTICTABLET1517
72789-393-20Prednisone20 in 1 BOTTLE, PLASTICTABLET2017
72789-393-21Prednisone21 in 1 BOTTLE, PLASTICTABLET2117
72789-393-25Prednisone25 in 1 BOTTLE, PLASTICTABLET2517
72789-393-30Prednisone30 in 1 BOTTLE, PLASTICTABLET3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-393PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, 12 package rows20250221_1349a022-639b-4494-99a2-1594c7c0f0e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN1349a022-639b-4494-99a2-1594c7c0f0e917
312615prednisone 20 MG Oral TabletSCD1349a022-639b-4494-99a2-1594c7c0f0e917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-393-02727890393022 TABLET in 1 BOTTLE, PLASTIC (72789-393-02) 2 tablet2024-07-30NoNoCurrent
72789-393-05727890393055 TABLET in 1 BOTTLE, PLASTIC (72789-393-05) 5 tablet2024-06-24NoNoCurrent
72789-393-06727890393066 TABLET in 1 BOTTLE, PLASTIC (72789-393-06) 6 tablet2024-05-06NoNoCurrent
72789-393-09727890393099 TABLET in 1 BOTTLE, PLASTIC (72789-393-09) 9 tablet2024-04-25NoNoCurrent
72789-393-107278903931010 TABLET in 1 BOTTLE, PLASTIC (72789-393-10) 10 tablet2024-04-25NoNoCurrent
72789-393-127278903931212 TABLET in 1 BOTTLE, PLASTIC (72789-393-12) 12 tablet2024-06-17NoNoCurrent
72789-393-147278903931414 TABLET in 1 BOTTLE, PLASTIC (72789-393-14) 14 tablet2024-05-21NoNoCurrent
72789-393-157278903931515 TABLET in 1 BOTTLE, PLASTIC (72789-393-15) 15 tablet2024-04-24NoNoCurrent
72789-393-207278903932020 TABLET in 1 BOTTLE, PLASTIC (72789-393-20) 20 tablet2024-04-19NoNoCurrent
72789-393-217278903932121 TABLET in 1 BOTTLE, PLASTIC (72789-393-21) 21 tablet2024-04-19NoNoCurrent
72789-393-257278903932525 TABLET in 1 BOTTLE, PLASTIC (72789-393-25) 25 tablet2024-04-19NoNoCurrent
72789-393-307278903933030 TABLET in 1 BOTTLE, PLASTIC (72789-393-30) 30 tablet2024-04-17NoNoCurrent