Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide NDC 42192-607
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 |
|---|---|---|---|
| 42192-607-04 | 42192060704 | 118 mL in 1 BOTTLE, PLASTIC (42192-607-04)Marketed from Sep 21, 2016 | |
| 42192-607-16 | 42192060716 | 473 mL in 1 BOTTLE, PLASTIC (42192-607-16)Marketed from Sep 21, 2016 |
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, 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 42192-607_4d260aef-5897-199f-e063-6394a90a522aSPL ID 4d260aef-5897-199f-e063-6394a90a522aSPL set ID 1045e307-f60d-482d-8e06-40e72b84c651RxCUI 1357010UNII IXA7C9ZN03, 6V9V2RYJ8N, 9D2RTI9KYHUPC 0342192607057, 0342192607040, 0342192607163
- 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
N442192060704followed by a unit qualifier and the quantityPackage 42192-0607-04. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.