Albuterol Sulfate

Product NDC
0591-3468
11-digit product format
005913468
Labeler code
0591
Product ID
0591-3468_822389a6-a2ba-498a-bf4e-ba76319ea127
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077772
Marketing category
ANDA
Marketing start
2007-09-25
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
1 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
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
0591-3468-53ML - Milliliter0591-346880c77a7b-81cc-403e-9e8d-689da36c154412012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3468-53005913468535 POUCH in 1 CARTON (0591-3468-53) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL5 pouch2007-09-250000-00-00NoNoCurrent