FDA.reportPublic FDA data

PredniSONE

Product NDC
17856-3722
11-digit product format
178563722
Labeler code
17856
Product ID
17856-3722_35d2e5c3-3d05-e219-e063-6294a90acf21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA088703
Marketing category
ANDA
Marketing start
1986-12-13
Substance
PREDNISONE
Active strength
5 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui315187

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3722-12025-04-18C16284748780-19d75b9d0-fb74-f424-e053-dadaa90a57cePredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL
17856-3722-12020-01-31C16284748780-19d75b9d0-fb74-f424-e053-dadaa90a57cePredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3722-1PredniSONE5 mL in 1 CUPSOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-3722-1ML - Milliliter17856-3722f033a8fb-c3ee-46f7-acd0-02b83afed87c12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3722PREDNISONE SOLUTION [ATLANTIC BIOLOGICALS CORPS]5Current NDC, Legacy NDC, 1 package rows20250525_07be390e-ef1e-4bf9-a9da-4338b5f6cfa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315187predniSONE 5 MG in 5 mL Oral SolutionPSN07be390e-ef1e-4bf9-a9da-4338b5f6cfa55
315187prednisone 1 MG/ML Oral SolutionSCD07be390e-ef1e-4bf9-a9da-4338b5f6cfa55
315187prednisone 5 MG per 5 ML Oral SolutionSY07be390e-ef1e-4bf9-a9da-4338b5f6cfa55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-3722-1178563722015 mL in 1 CUP (17856-3722-1) 5 ml2016-05-05NoNoHistorical