Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide NDC 0121-0933
Brompheniramine maleate 2 mg/5mL + 2 more ingredients · Solution · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0933-04 | 00121093304 | 118 mL in 1 BOTTLE (0121-0933-04)Marketed from Mar 3, 2022 | |
| 0121-0933-16 | 00121093316 | 473 mL in 1 BOTTLE (0121-0933-16)Marketed from Mar 3, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Brompheniramine maleate — 2 mg/5mLPseudoephedrine hydrochloride — 30 mg/5mLDextromethorphan hydrobromide — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202940
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0121-0933_44a05fe1-89fe-4252-b0b8-1ce678a4c6a7SPL ID 44a05fe1-89fe-4252-b0b8-1ce678a4c6a7SPL set ID 01ea6357-24dc-4056-9fd2-9e643650b91fRxCUI 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
N400121093304followed by a unit qualifier and the quantityPackage 00121-0933-04. 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.