Guaifenesin And Dextromethorphan Syrup
NDC Package 0904-7513-72
Package Information
Guaifenesin And Dextromethorphan syrups is follow dosage below or use as directed by a physician. This formulation utilizes a syrup delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-7513 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution
Clinical Specifications
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- 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)
Regulatory & Marketing
Hierarchy Structure
- 0904 - Major Pharmaceuticals
- 0904-7513 - Guaifenesin And Dextromethorphan
- 0904-7513-72 - 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7513-66)
- 0904-7513 - Guaifenesin And Dextromethorphan
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 0904-7513-72 identifies a specific commercial package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose (0904-7513-66) of Guaifenesin And Dextromethorphan, a human over the counter drug labeled by Major Pharmaceuticals. This syrup is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin 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 Major Pharmaceuticals on February 10, 2025. The current certification is valid through December 31, 2026.
How is this Major Pharmaceuticals product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904751372. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 Labeler segment to maintain the 5-4-2 structure.