Ipratropium Bromide and Albuterol Sulfate

Product NDC
70518-2627
11-digit product format
705182627
Labeler code
70518
Product ID
70518-2627_d6e1d87c-57c0-489b-e053-2a95a90a69e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA077559
Marketing category
ANDA
Marketing start
2020-03-12
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2627-02022-01-31C16284748780-1d6a99b39-cadd-a426-e053-dadaa90af4c2291c1c7b-b905-43a5-947f-903e5415b4d0
70518-2627-02022-01-28C16284748780-1d6a99b39-cadd-a426-e053-dadaa90af4c2291c1c7b-b905-43a5-947f-903e5415b4d0

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2627-07051826270012 POUCH in 1 CARTON (70518-2627-0) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL12 pouch2020-03-120000-00-00NoNoCurrent