FDA.reportPublic FDA data

PredniSONE

Product NDC
51655-355
11-digit product format
516550355
Labeler code
51655
Product ID
51655-355_48eb7028-8433-010d-e063-6294a90a59d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA080352
Marketing category
ANDA
Marketing start
2020-05-28
Substance
PREDNISONE
Active strength
5 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
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-355-262023-03-27C16284748780-1f386c649-e5d3-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-355-262023-01-30C16284748780-1f386c649-e5d3-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-355-26PredniSONE90 in 1 BOTTLE, PLASTICTABLET905
51655-355-52PredniSONE30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-355PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241219_ab315be2-8d13-be25-e053-2995a90a5184.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNab315be2-8d13-be25-e053-2995a90a51845
312617prednisone 5 MG Oral TabletSCDab315be2-8d13-be25-e053-2995a90a51845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-355-265165503552690 TABLET in 1 BOTTLE, PLASTIC (51655-355-26) 90 tablet2020-05-280000-00-00NoNoCurrent
51655-355-525165503555230 TABLET in 1 BOTTLE, PLASTIC (51655-355-52) 30 tablet2021-02-02NoNoCurrent