Budesonide

Product NDC
51079-020
11-digit product format
510790020
Labeler code
51079
Product ID
51079-020_d3aed0a8-89a3-525c-e053-2995a90a7d37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA090410
Marketing category
ANDA
Marketing start
2011-09-02
Marketing end
2022-04-30
Substance
BUDESONIDE
Active strength
3 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-020-01EA - Each51079-0202bdb6a74-9e55-42f3-bced-9ad3e1267fa312012-07-24
51079-020-03EA - Each51079-020479af571-ed2b-478e-b2a4-b5d2b4d45aa212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-020-035107900200330 BLISTER PACK in 1 CARTON (51079-020-03) > 1 CAPSULE in 1 BLISTER PACK (51079-020-01) 30 blister pack2011-09-020000-00-00NoNoCurrent