Albuterol Sulfate Inhalation Solution

Product NDC
65302-060
11-digit product format
653020060
Labeler code
65302
Product ID
65302-060_f06cec73-d56c-eb04-e053-2a95a90a4d50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
The Ritedose Corporation
Application
ANDA214531
Marketing category
ANDA
Marketing start
2022-01-04
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65302-060-016530200600130 POUCH in 1 CARTON (65302-060-01) > 1 AMPULE in 1 POUCH > 3 mL in 1 AMPULE30 pouch2022-01-040000-00-00NoNoCurrent
65302-060-056530200600525 POUCH in 1 CARTON (65302-060-05) > 5 AMPULE in 1 POUCH > 3 mL in 1 AMPULE25 pouch2022-01-040000-00-00NoNoCurrent