Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Product NDC
63629-2086
11-digit product format
636292086
Labeler code
63629
Product ID
63629-2086_64b900f9-25a6-4639-baec-c59895d1bb1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213125
Marketing category
ANDA
Marketing start
2020-04-17
Marketing end
2023-12-31
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
63629-2086-1ML - Milliliter63629-2086cecc75ca-c5c2-4c77-8e3d-f6a029d1d74b12021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2086-163629208601118 mL in 1 BOTTLE, PLASTIC (63629-2086-1) 118 ml2020-04-172023-12-31NoNoCurrent