Prednisolone Sodium Phosphate

Product NDC
0378-4715
11-digit product format
003784715
Labeler code
0378
Product ID
0378-4715_13adacbf-c730-4753-bdb5-eaa24d8494c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202179
Marketing category
ANDA
Marketing start
2014-12-08
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
15 mg/1
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
0378-4715-22EA - Each0378-47158d886d9c-3915-4e8c-91f9-80b57695418312015-01-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4715-220037847152248 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-4715-22) 2014-12-080000-00-00NoNoCurrent