PEDIAPRED

Product NDC
68791-104
11-digit product format
687910104
Labeler code
68791
Product ID
68791-104_5e5a5e2b-b12a-42d8-b375-11fbffb050b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Royal Pharmaceuticals
Application
NDA019157
Marketing category
NDA
Marketing start
2018-02-07
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
5 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68791-104-04ML - Milliliter68791-104e833ccee-7fa7-4e32-8b0f-324bb577db3812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68791-104PEDIAPRED (PREDNISOLONE SODIUM PHOSPHATE) SOLUTION [ROYAL PHARMACEUTICALS]4Legacy NDC20240203_1b996564-a777-4d37-ae00-b6a5ffc5e596.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68791-104-0468791010404120 mL in 1 BOTTLE (68791-104-04) 120 ml2018-02-070000-00-00NoNoCurrent