Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Product NDC
63629-2058
11-digit product format
636292058
Labeler code
63629
Product ID
63629-2058_176eae46-be40-4621-adbb-3e06621dfbd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
SYRUP
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203997
Marketing category
ANDA
Marketing start
2020-09-30
Marketing end
2022-12-31
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2058-1ML - Milliliter63629-2058dd6fd632-0307-41fc-95ae-0386322ed86612021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2058-163629205801473 mL in 1 BOTTLE (63629-2058-1) 473 ml2020-09-302022-12-31NoNoCurrent