Ipratropium Bromide and Albuterol Sulfate

Product NDC
70518-3347
11-digit product format
705183347
Labeler code
70518
Product ID
70518-3347_e5584fe6-a8fc-dfaa-e053-2a95a90abece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA202496
Marketing category
ANDA
Marketing start
2022-01-28
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength
3 mg/3mL; mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [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
70518-3347-07051833470060 POUCH in 1 CARTON (70518-3347-0) > 1 AMPULE in 1 POUCH > 3 mL in 1 AMPULE60 pouch2022-01-280000-00-00NoNoCurrent