brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide

Product NDC
68788-7610
11-digit product format
687887610
Labeler code
68788
Product ID
68788-7610_803c7be8-1027-4eac-aa41-b711455d3157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207676
Marketing category
ANDA
Marketing start
2020-02-13
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7610-1ML - Milliliter68788-7610f8c0bb2d-90f7-4b94-919f-729ee13a2a8912020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7610-168788761001118 mL in 1 BOTTLE, PLASTIC (68788-7610-1) 118 ml2020-02-130000-00-00NoNoCurrent