FDA.reportPublic FDA data

PREDNISONE

Product NDC
71335-2389
11-digit product format
713352389
Labeler code
71335
Product ID
71335-2389_1fb23895-41de-4fe6-92fc-1b6d6721b73a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215672
Marketing category
ANDA
Marketing start
2022-03-28
Substance
PREDNISONE
Active strength
50 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
PREDNISONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198148

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
71335-2389-1PREDNISONE90 in 1 BOTTLETABLET901
71335-2389-2PREDNISONE5 in 1 BOTTLETABLET51
71335-2389-3PREDNISONE30 in 1 BOTTLETABLET301
71335-2389-4PREDNISONE60 in 1 BOTTLETABLET601
71335-2389-5PREDNISONE120 in 1 BOTTLETABLET1201
71335-2389-6PREDNISONE7 in 1 BOTTLETABLET71
71335-2389-7PREDNISONE20 in 1 BOTTLETABLET201
71335-2389-8PREDNISONE10 in 1 BOTTLETABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2389PREDNISONE TABLET [BRYANT RANCH PREPACK]1Current NDC, 8 package rows20240531_7601e38d-b7d2-4292-b16e-abff32bb46b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSN7601e38d-b7d2-4292-b16e-abff32bb46b31
198148prednisone 50 MG Oral TabletSCD7601e38d-b7d2-4292-b16e-abff32bb46b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2389-17133523890190 TABLET in 1 BOTTLE (71335-2389-1) 90 tablet2024-05-29NoNoHistorical
71335-2389-2713352389025 TABLET in 1 BOTTLE (71335-2389-2) 5 tablet2024-05-29NoNoHistorical
71335-2389-37133523890330 TABLET in 1 BOTTLE (71335-2389-3) 30 tablet2024-05-29NoNoHistorical
71335-2389-47133523890460 TABLET in 1 BOTTLE (71335-2389-4) 60 tablet2024-05-29NoNoHistorical
71335-2389-571335238905120 TABLET in 1 BOTTLE (71335-2389-5) 120 tablet2024-05-29NoNoHistorical
71335-2389-6713352389067 TABLET in 1 BOTTLE (71335-2389-6) 7 tablet2024-05-29NoNoHistorical
71335-2389-77133523890720 TABLET in 1 BOTTLE (71335-2389-7) 20 tablet2024-05-29NoNoHistorical
71335-2389-87133523890810 TABLET in 1 BOTTLE (71335-2389-8) 10 tablet2024-05-29NoNoHistorical