Ipratropium Bromide and Albuterol Sulfate

Product NDC
68788-7678
11-digit product format
687887678
Labeler code
68788
Product ID
68788-7678_dcdda75a-3d52-49a2-aa5f-fdd276a8fe4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide and Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076749
Marketing category
ANDA
Marketing start
2020-02-28
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7678-3ML - Milliliter68788-7678874059ff-e343-4f44-9a69-532ad8b0091a12020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7678-36878876780330 POUCH in 1 CARTON (68788-7678-3) > 1 VIAL, SINGLE-USE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-USE30 pouch2020-02-280000-00-00NoNoCurrent