Budesonide

Product NDC
68788-7290
11-digit product format
687887290
Labeler code
68788
Product ID
68788-7290_95bfc13d-d92a-4d98-a328-890337d95556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
INHALANT
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA205710
Marketing category
ANDA
Marketing start
2019-01-21
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
0 mg/2mL
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
68788-7290-3ML - Milliliter68788-7290aea882b1-6699-48e3-b064-3305ed99091912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7290BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [PREFERRED PHARMACEUTICALS INC.]7Legacy NDC20250210_61b907a0-80f4-4a46-8d5b-29c2eedaa17a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7290-3687887290036 POUCH in 1 CARTON (68788-7290-3) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE6 pouch2019-01-210000-00-00NoNoCurrent