Prednisolone Sodium Phosphate Oral Solution

Product NDC
0178-0582
11-digit product format
001780582
Labeler code
0178
Product ID
0178-0582_78d3451f-951d-1d42-e053-2991aa0ad2b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Mission Pharmacal Company
Application
ANDA091396
Marketing category
ANDA
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
25 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0582-01ML - Milliliter0178-05827fb9a5a1-2b43-4d7a-b740-663ace7b331b12018-03-08
0178-0582-08ML - Milliliter0178-05824bbdd13f-afc1-4b8e-a183-bbf068bbfd0d12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0582-010017805820130 mL in 1 BOTTLE (0178-0582-01) 30 ml2012-10-010000-00-00NoNoCurrent
0178-0582-0800178058208237 mL in 1 BOTTLE (0178-0582-08) 237 ml2012-10-010000-00-00NoNoCurrent