Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide NDC 85766-250
Brompheniramine maleate 2 mg/5mL + 2 more ingredients · Syrup · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-250-04 | 85766025004 | 118 mL in 1 BOTTLE, PLASTIC (85766-250-04)Marketed from Jul 24, 2026 | |
| 85766-250-16 | 85766025016 | 473 mL in 1 BOTTLE, PLASTIC (85766-250-16)Marketed from Jul 24, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
- Active ingredients
- Brompheniramine maleate — 2 mg/5mLPseudoephedrine hydrochloride — 30 mg/5mLDextromethorphan hydrobromide — 10 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203375
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85766-250_575430f0-08c6-a7eb-e063-6394a90ac220SPL ID 575430f0-08c6-a7eb-e063-6394a90ac220SPL set ID f3afca82-ba8f-4741-8332-b7939aa0ee5eRxCUI 1357010UNII IXA7C9ZN03, 6V9V2RYJ8N, 9D2RTI9KYH
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485766025004followed by a unit qualifier and the quantityPackage 85766-0250-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203375
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Proficient Rx LP | 63187-930 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Acella Pharmaceuticals, LLC | 42192-607 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Acella Pharmaceuticals, LLC | 42192-630 |