Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Product NDC
68788-7861
11-digit product format
687887861
Labeler code
68788
Product ID
68788-7861_38e8e5eb-e6ba-4ef2-bf2e-81ba306fbdea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA088811
Marketing category
ANDA
Marketing start
2021-02-08
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7861-1ML - Milliliter68788-7861e9c5179a-fe8d-4dcb-acb4-0b1421e2482e12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7861-168788786101118 mL in 1 BOTTLE, PLASTIC (68788-7861-1) 118 ml2021-02-080000-00-00NoNoCurrent