Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide NDC 42192-630
Brompheniramine maleate 2 mg/5mL + 2 more ingredients · Syrup · Oral · Acella Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42192-630-04 | 4219206300442192063004 | 118 mL in 1 BOTTLE, PLASTIC (42192-630-04)Marketed from Feb 1, 2025 | |
| 42192-630-16 | 4219206301642192063016 | 473 mL in 1 BOTTLE, PLASTIC (42192-630-16)Marketed from Feb 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, 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
- Acella Pharmaceuticals, LLCNDC labeler code 42192
- 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 42192-630_4138efd9-8584-c8db-e063-6294a90adcd7SPL ID 4138efd9-8584-c8db-e063-6294a90adcd7SPL set ID 0c403f27-0b9b-4da3-a66b-1040eff1b2bfRxCUI 1357010UNII IXA7C9ZN03, 6V9V2RYJ8N, 9D2RTI9KYHUPC 0342192630048, 0342192630161
- 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
N442192063004followed by a unit qualifier and the quantityPackage 42192-0630-04. 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.
About NDC 42192-630
- What is NDC 42192-630?
- 42192-630 is the product NDC for Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, Brompheniramine maleate 2 mg/5mL + 2 more ingredients syrup, listed with the FDA by Acella Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide).
- What is the active ingredient?
- Brompheniramine maleate, Pseudoephedrine hydrochloride, Dextromethorphan hydrobromide.
- Who is the labeler?
- Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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, Dextromethorphan Hydrobromide?
- 3 other product NDCs are listed under this name. See all Brompheniramine Maleate, Pseudoephedrine Hydrochloride, 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, 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, Dextromethorphan Hydrobromidebrompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Sportpharm LLC | 85766-250 | 85766-0250-0485766-0250-16 |
| 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 | 42192-0607-0442192-0607-16 |
| 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 | 63187-0930-0463187-0930-16 |
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 | 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 | 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 | Sportpharm LLC | 85766-250 |