Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC
68788-6453
11-digit product format
687886453
Labeler code
68788
Product ID
68788-6453_2bd2cde7-d621-49de-a456-dc21551a1ae3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA205292
Marketing category
ANDA
Marketing start
2016-08-05
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record