Ipratropium Bromide and Albuterol Sulfate

Product NDC
0591-3817
11-digit product format
005913817
Labeler code
0591
Product ID
0591-3817_df9ab76d-0872-4caf-a135-5478a90166de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide and albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Actavis Pharma, Inc.
Application
ANDA202496
Marketing category
ANDA
Marketing start
2013-05-13
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE; ALBUTEROL SULFATE
Active strength
1 mg/3mL; mg/3mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA],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
0591-3817-30ML - Milliliter0591-3817d9b3d6de-8293-48a4-b969-6c8cd628075712013-06-04
0591-3817-39ML - Milliliter0591-3817d2bee250-51b8-4adf-9c8c-1c663ab04f2c12016-04-04
0591-3817-60ML - Milliliter0591-38177875fc93-699e-42b2-8cba-0233660e438912013-06-04
0591-3817-66ML - Milliliter0591-3817add82d05-c2e6-46f1-a2d4-c8d393f4114a12016-04-04