NDC 42192-607

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Acella Pharmaceuticals, Llc. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID	42192-607_5b23a410-18e1-b8d7-e053-2a91aa0ae330
NDC	42192-607
Product Type	Human Prescription Drug
Proprietary Name	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Generic Name	Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Dosage Form	Syrup
Route of Administration	ORAL
Marketing Start Date	2016-09-21
Marketing Category	ANDA / ANDA
Application Number	ANDA203375
Labeler Name	Acella Pharmaceuticals, LLC
Substance Name	BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength	2 mg/5mL; mg/5mL; mg/5mL
Pharm 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	N
Listing Certified Through	2019-12-31

Packaging

NDC 42192-607-04

118 mL in 1 BOTTLE, PLASTIC (42192-607-04)

Marketing Start Date	2016-09-21
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 42192-607-04 [42192060704]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP

Marketing Category	ANDA
Application Number	ANDA203375
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	ML
Marketing Start Date	2016-09-21

NDC 42192-607-16 [42192060716]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP

Marketing Category	ANDA
Application Number	ANDA203375
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	ML
Marketing Start Date	2016-09-21

NDC 42192-607-40 [42192060740]

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP

Marketing Category	ANDA
Application Number	ANDA203375
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2016-09-21

Drug Details

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

SPL SET ID:	1045e307-f60d-482d-8e06-40e72b84c651
Manufacturer	Acella Pharmaceuticals, LLC
UNII	6V9V2RYJ8N 9D2RTI9KYH IXA7C9ZN03
RxNorm Concept Unique ID - RxCUI	1357010
UPC Code	0342192607163 0342192607040

Pharmacological Class

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]

Medicade Reported Pricing

42192060716 BROMPHENIR-PSEUDOEPHED-DM SYR

Pricing Unit: ML | Drug Type:

42192060704 BROMPHENIR-PSEUDOEPHED-DM SYR

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide" or generic name "Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide"