Budesonide

Product NDC
64980-255
11-digit product format
649800255
Labeler code
64980
Product ID
64980-255_bdd1994f-fecc-41e9-ad6b-bd6bfcf049e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA207367
Marketing category
ANDA
Marketing start
2017-08-30
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-255-01EA - Each64980-255834e7d2a-ee3c-46b3-a334-55ada122883212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-255BUDESONIDE CAPSULE [RISING PHARMACEUTICALS, INC.]4Legacy NDC20181010_2c2ce3a8-7125-4ee0-afae-73a9cac8fd31.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-255-0164980025501100 CAPSULE in 1 BOTTLE (64980-255-01) 100 capsule2017-08-300000-00-00NoNoCurrent