Budesonide

Product NDC
16714-019
11-digit product format
167140019
Labeler code
16714
Product ID
16714-019_9bbd2475-b4f2-4776-b59e-add17f17984b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
INHALANT
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA205710
Marketing category
ANDA
Marketing start
2020-11-11
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
1 mg/2mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-019-05ML - Milliliter16714-019a4bd6b2c-9abf-4afe-926e-a48995dedd4b12021-02-05
16714-019-30ML - Milliliter16714-019457c861e-0cb3-4582-9d03-be2e789d0a9c12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-019BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [NORTHSTAR RXLLC]3Legacy NDC20240921_ba9bbecc-5d2e-4b21-9934-23bb919e7623.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-019-30167140019306 POUCH in 1 CARTON (16714-019-30) > 5 AMPULE in 1 POUCH (16714-019-05) > 2 mL in 1 AMPULE6 pouch2020-11-110000-00-00NoNoCurrent