brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Product NDC
71205-346
11-digit product format
712050346
Labeler code
71205
Product ID
71205-346_2daad986-907a-4b6c-baae-e465c1bb38f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207676
Marketing category
ANDA
Marketing start
2019-02-06
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-346BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [PROFICIENT RX LP]1Legacy NDC20191115_2daad986-907a-4b6c-baae-e465c1bb38f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-346-0471205034604118 mL in 1 BOTTLE, PLASTIC (71205-346-04) 118 ml2019-11-010000-00-00NoNoCurrent