BUDESONIDE (ENTERIC COATED)

Product NDC
51407-128
11-digit product format
514070128
Labeler code
51407
Product ID
51407-128_dd0aa3fe-97f3-4130-e053-2995a90a3a48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA206623
Marketing category
ANDA
Marketing start
2016-04-08
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
3 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-128-01EA - Each51407-128c8387fa4-4f4d-42fa-892b-abd3d71fc84412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-128BUDESONIDE (ENTERIC COATED) (BUDESONIDE) CAPSULE, DELAYED RELEASE PELLETS [GOLDEN STATE MEDICAL SUPPLY, INC.]4Legacy NDC20240110_c5d97b04-e206-4325-e053-2a95a90ab610.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-128-0151407012801100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51407-128-01) 2021-06-280000-00-00NoNoCurrent