Broncochem Tablet, Coated
NDC Package 65131-101-11
Package Information
Broncochem (acetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate) tablets is bronchial congestion, irritation of the respiratory passages, nasal congestion.Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis Adults and children 12 years and over, take one tablet every 4 hours.Do not exceed 6 doses in a 24 hour period. This formulation utilizes a tablet, coated delivery system. Marketed by Laboratorio Magnachem International Srl, this product is identified by NDC 65131-101 and is authorized under FDA application C200263.
Identification & Billing
- RxCUI: 2709229 - acetaminophen 325 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Oral Tablet
- RxCUI: 2709229 - acetaminophen 325 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Oral Tablet
- RxCUI: 2709229 - APAP 325 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 65131 - Laboratorio Magnachem International Srl
- 65131-101 - Broncochem
- 65131-101-11 - 50 POUCH in 1 BOX / 2 TABLET, COATED in 1 POUCH
- 65131-101 - Broncochem
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 65131-101-11 identifies a specific commercial package of 50 pouch in 1 box / 2 tablet, coated in 1 pouch of Broncochem Cold And Flu Caplets, a human over the counter drug labeled by Laboratorio Magnachem International Srl. This tablet, coated is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Laboratorio Magnachem International Srl on January 01, 2010. The current certification is valid through December 31, 2026.
How is this Laboratorio Magnachem International Srl product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65131010111. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.