Prescription drug · ANDA
Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDC 72162-2039
Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL · Solution · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2039-2 | 72162203902 | 473 mL in 1 BOTTLE, PLASTIC (72162-2039-2)Marketed from Jun 6, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- promethazine hydrochloride and dextromethorphan hydrobromide
- Active ingredients
- Promethazine hydrochloride — 6.25 mg/5mLDextromethorphan hydrobromide — 15 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091687
- Marketing start
- Marketing end
- Other FDA classes
- Phenothiazines (Chemical structure)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72162-2039_4c93b759-804b-4e84-ba5d-37bb0895adf7SPL ID 4c93b759-804b-4e84-ba5d-37bb0895adf7SPL set ID 709519cb-d124-4469-b329-b67e1bba214bRxCUI 991528UNII R61ZEH7I1I, 9D2RTI9KYH
- Pharmacologic class
- Phenothiazine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N472162203902followed by a unit qualifier and the quantityPackage 72162-2039-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091687
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 |
|---|---|---|---|---|
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-6755 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Cosette Pharmaceuticals, Inc. | 0713-0780 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Cranbury Pharmaceuticals, LLC | 27808-057 |