Ipratropium Bromide and Albuterol Sulfate

Product NDC
70518-2250
11-digit product format
705182250
Labeler code
70518
Product ID
70518-2250_d9ccb47b-a819-152c-e053-2a95a90a1565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA076749
Marketing category
ANDA
Marketing start
2019-08-02
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
70518-2250-07051822500010 POUCH in 1 CARTON (70518-2250-0) > 6 VIAL, SINGLE-USE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-USE10 pouch2019-08-020000-00-00NoNoCurrent
70518-2250-1705182250015 POUCH in 1 CARTON (70518-2250-1) > 6 VIAL, SINGLE-USE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-USE5 pouch2022-03-080000-00-00NoNoCurrent