Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide NDC 69452-478
Dextromethorphan hydrobromide 10 mg/5mL + 2 more ingredients · Syrup · Oral · BIONPHARMA INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69452-478Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0478Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-478-55 | 6945204785569452047855 | 118 mL in 1 BOTTLE (69452-478-55)Marketed from Oct 1, 2025 | |
| 69452-478-88 | 6945204788869452047888 | 473 mL in 1 BOTTLE (69452-478-88)Marketed from Oct 1, 2025 |
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, and Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
- Active ingredients
- Dextromethorphan hydrobromide — 10 mg/5mLPseudoephedrine hydrochloride — 30 mg/5mLBrompheniramine maleate — 2 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- BIONPHARMA INC.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203997
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69452-478_3ff18027-44fc-50a1-e063-6394a90a2390SPL ID 3ff18027-44fc-50a1-e063-6394a90a2390SPL set ID 3ff18027-44fb-50a1-e063-6394a90a2390RxCUI 1357010UNII 9D2RTI9KYH, 6V9V2RYJ8N, IXA7C9ZN03UPC 0369452478882
- 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
N469452047855followed by a unit qualifier and the quantityPackage 69452-0478-55. 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 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.
About NDC 69452-478
- What is NDC 69452-478?
- 69452-478 is the product NDC for Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide, Dextromethorphan hydrobromide 10 mg/5mL + 2 more ingredients syrup, listed with the FDA by BIONPHARMA INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide.
- What is the active ingredient?
- Dextromethorphan hydrobromide, Pseudoephedrine hydrochloride, Brompheniramine maleate.
- Who is the labeler?
- BIONPHARMA INC., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide?
- 11 other product NDCs are listed under this name. See all Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | REMEDYREPACK INC. | 70518-4526 | 70518-4526-0070518-4526-0270518-4526-04 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Dr. Reddy's Labratories Inc. | 75907-207 | 75907-0207-0475907-0207-16 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0933 | 00121-0933-0400121-0933-16 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Chartwell RX, LLC | 62135-302 | 62135-0302-2462135-0302-4762135-0302-48 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Chartwell Governmental & Specialty RX, LLC | 68999-302 | 68999-0302-24 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Padagis US LLC | 0574-1104 | 00574-1104-0400574-1104-16 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | A-S Medication Solutions | 50090-5625 | 50090-5625-00 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Proficient Rx LP | 63187-664 | 63187-0664-04 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Bryant Ranch Prepack | 63629-8615 | 63629-8615-01 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Bryant Ranch Prepack | 63629-8616 | 63629-8616-01 |