Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide

Product NDC
63187-400
11-digit product format
631870400
Labeler code
63187
Product ID
63187-400_7f00edf4-7b75-4ba8-9685-5f7c6326d0ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA088811
Marketing category
ANDA
Marketing start
2010-06-15
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Brompheniramine MaleateACTIVE INGREDIENTIXA7C9ZN03BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
BrompheniramineACTIVE MOIETYH57G17P2FNBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
DextromethorphanACTIVE MOIETY7355X3ROTSBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
AlcoholINACTIVE INGREDIENT3K9958V90MBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOABROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
SucroseINACTIVE INGREDIENTC151H8M554BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-400BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHANHYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PROFICIENT RX LP]3Legacy NDC20200515_871632bb-0525-4e3b-a3ab-a50393bc9634.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-400-0463187040004118 mL in 1 BOTTLE, PLASTIC (63187-400-04) 118 ml2019-01-010000-00-00NoNoCurrent