Entocort EC

Product NDC
0574-9850
11-digit product format
005749850
Labeler code
0574
Product ID
0574-9850_8d53681c-2c90-4406-8229-2fbd78ecf5d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
CAPSULE
Route
ORAL
Labeler
Padagis US LLC
Application
NDA021324
Marketing category
NDA
Marketing start
2001-10-29
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
3 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-9850-10EA - Each0574-9850b40e7e19-ce98-4939-9ea0-1afc9391c2ff12016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-9850-1000574985010100 CAPSULE in 1 BOTTLE (0574-9850-10) 100 capsule2001-10-290000-00-00NoNoCurrent