PredniSONE

Product NDC
51655-726
11-digit product format
516550726
Labeler code
51655
Product ID
51655-726_c9f470d4-8b55-97e8-e053-2a95a90ac3ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA084122
Marketing category
ANDA
Marketing start
2021-06-10
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
51655-726-212023-03-27C16284748780-1f386c64a-30bc-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-726-212023-01-30C16284748780-1f386c64a-30bc-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-726-21PredniSONE21 in 1 BOTTLE, PLASTICTABLET213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-726PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Legacy NDC, 1 package rows20241228_c9f4711d-319c-d952-e053-2a95a90a3697.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNc9f4711d-319c-d952-e053-2a95a90a36973
198145prednisone 10 MG Oral TabletSCDc9f4711d-319c-d952-e053-2a95a90a36973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-726-215165507262121 TABLET in 1 BOTTLE, PLASTIC (51655-726-21) 21 tablet2021-06-100000-00-00NoNoCurrent