RHINOCORT Allergy

Product NDC
50580-646
11-digit product format
505800646
Labeler code
50580
Product ID
50580-646_d6a4bfc1-33f0-5a33-e053-2995a90a0a64
Type
HUMAN OTC DRUG
Nonproprietary name
budesonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application
NDA020746
Marketing category
NDA
Marketing start
2016-01-14
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
32 ug/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
50580-646-01ML - Milliliter50580-646e7f475e4-d0c7-4f99-a1cd-bec50a3a4e2212016-03-04
50580-646-02ML - Milliliter50580-646d1e819d7-12ef-4112-8722-6b27a85bf7fe12016-03-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-646-02505800646021 BOTTLE in 1 CARTON (50580-646-02) > 120 SPRAY, METERED in 1 BOTTLE1 bottle2016-01-140000-00-00NoNoCurrent
50580-646-03505800646033 CARTON in 1 PACKAGE (50580-646-03) > 1 BOTTLE in 1 CARTON (50580-646-02) > 120 SPRAY, METERED in 1 BOTTLE3 carton2016-01-140000-00-00NoNoCurrent