FDA.reportPublic FDA data

PredniSONE

Product NDC
0054-9817
11-digit product format
000549817
Labeler code
0054
Product ID
0054-9817_249c4c6d-a058-489a-8f84-928c14bfd3f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080352
Marketing category
ANDA
Marketing start
2020-03-23
Substance
PREDNISONE
Active strength
10 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
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 312615, 312617

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
0054-9817-252022-08-04C16284748780-1e4f33bdf-a8c9-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP
0054-9817-292022-08-04C16284748780-1e4f33bdf-a8c9-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP
0054-9817-252022-07-29C16284748780-1e4f33bdf-a8c9-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP
0054-9817-292022-07-29C16284748780-1e4f33bdf-a8c9-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-9817-25PredniSONE100 in 1 BOTTLETABLET1008
0054-9817-29PredniSONE500 in 1 BOTTLETABLET5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-9817PREDNISONE TABLET [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250423_263ed4fa-3c29-4abb-9cb1-bc016bd34a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN263ed4fa-3c29-4abb-9cb1-bc016bd34a058
312615predniSONE 20 MG Oral TabletPSN263ed4fa-3c29-4abb-9cb1-bc016bd34a058
312617predniSONE 5 MG Oral TabletPSN263ed4fa-3c29-4abb-9cb1-bc016bd34a058
198145prednisone 10 MG Oral TabletSCD263ed4fa-3c29-4abb-9cb1-bc016bd34a058
312615prednisone 20 MG Oral TabletSCD263ed4fa-3c29-4abb-9cb1-bc016bd34a058
312617prednisone 5 MG Oral TabletSCD263ed4fa-3c29-4abb-9cb1-bc016bd34a058
198145predniSONE 10 MG Oral TabletPSN94715919-70bd-46c9-95fc-e151adf39cf96
198145prednisone 10 MG Oral TabletSCD94715919-70bd-46c9-95fc-e151adf39cf96
198145predniSONE 10 MG Oral TabletPSNc9f4711d-319c-d952-e053-2a95a90a36973
198145prednisone 10 MG Oral TabletSCDc9f4711d-319c-d952-e053-2a95a90a36973
198145predniSONE 10 MG Oral TabletPSN2e630aa1-eccd-f5eb-e063-6294a90a47451
312617predniSONE 5 MG Oral TabletPSN2e630aa1-eccd-f5eb-e063-6294a90a47451
198145prednisone 10 MG Oral TabletSCD2e630aa1-eccd-f5eb-e063-6294a90a47451
312617prednisone 5 MG Oral TabletSCD2e630aa1-eccd-f5eb-e063-6294a90a47451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-9817-2500054981725100 TABLET in 1 BOTTLE (0054-9817-25) 100 tablet2020-03-230000-00-00NoNoCurrent
0054-9817-2900054981729500 TABLET in 1 BOTTLE (0054-9817-29) 500 tablet2020-03-230000-00-00NoNoCurrent