LONHALA MAGNAIR

Product NDC
63402-301
11-digit product format
634020301
Labeler code
63402
Product ID
63402-301_7ecfca2a-729b-43fd-a71e-a4560b826981
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sunovion Pharmaceuticals Inc.
Application
NDA208437
Marketing category
NDA
Marketing start
2018-01-29
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
25 ug/mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [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
63402-301-01ML - Milliliter63402-3017b66a715-4534-46e4-8308-bfb7f83a394e12018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63402-301-01634020301011 CARTON in 1 KIT (63402-301-01) > 30 POUCH in 1 CARTON > 2 VIAL, SINGLE-DOSE in 1 POUCH > 1 mL in 1 VIAL, SINGLE-DOSE1 carton2018-01-290000-00-00NoNoCurrent