FDA.reportPublic FDA data

PredniSONE

Product NDC
50090-6619
11-digit product format
500906619
Labeler code
50090
Product ID
50090-6619_6866c32d-8ecf-41b3-846f-d0cb9f820a26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6619-0PredniSONE21 in 1 BOTTLETABLET211
50090-6619-1PredniSONE50 in 1 BOTTLETABLET501
50090-6619-3PredniSONE100 in 1 BOTTLETABLET1001
50090-6619-4PredniSONE30 in 1 BOTTLETABLET301
50090-6619-7PredniSONE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6619-0EA - Each50090-6619cfd13be2-40d3-444e-999b-62cb435992c512023-10-16
50090-6619-1EA - Each50090-6619dd3a881a-b4f9-43d9-8bdb-6b0dfb3dddf012023-10-16
50090-6619-3EA - Each50090-66190d35bc9a-57a8-4ae3-bf7e-8e0c700c44a712023-10-16
50090-6619-4EA - Each50090-6619fa09e338-ba86-466f-bdbb-f5b51c8160ba12023-10-16
50090-6619-7EA - Each50090-66196d9db078-c640-406e-ba92-45bd37e91a1912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6619PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 5 package rows20230901_f11c190e-edf8-454d-82c4-1ed769b5a6d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNf11c190e-edf8-454d-82c4-1ed769b5a6d21
312617prednisone 5 MG Oral TabletSCDf11c190e-edf8-454d-82c4-1ed769b5a6d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6619-05009066190021 TABLET in 1 BOTTLE (50090-6619-0) 21 tablet2023-08-24NoNoCurrent
50090-6619-15009066190150 TABLET in 1 BOTTLE (50090-6619-1) 50 tablet2023-08-24NoNoCurrent
50090-6619-350090661903100 TABLET in 1 BOTTLE (50090-6619-3) 100 tablet2023-08-24NoNoCurrent
50090-6619-45009066190430 TABLET in 1 BOTTLE (50090-6619-4) 30 tablet2023-08-24NoNoCurrent
50090-6619-75009066190760 TABLET in 1 BOTTLE (50090-6619-7) 60 tablet2023-08-24NoNoCurrent