PredniSONE

Product NDC
60760-796
11-digit product format
607600796
Labeler code
60760
Product ID
60760-796_16ee68eb-d166-3dc2-e063-6394a90aabd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA080352
Marketing category
ANDA
Marketing start
2020-03-23
Substance
PREDNISONE
Active strength
5 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
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617

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
60760-796-21PredniSONE21 in 1 BOTTLE, PLASTICTABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-796PREDNISONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20240426_16ee689e-c7a9-3a5a-e063-6394a90a6ea2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN16ee689e-c7a9-3a5a-e063-6394a90a6ea21
312617prednisone 5 MG Oral TabletSCD16ee689e-c7a9-3a5a-e063-6394a90a6ea21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-796-216076007962121 TABLET in 1 BOTTLE, PLASTIC (60760-796-21) 21 tablet2024-04-09NoNoCurrent