Prescription drug · ANDA
Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDC 0116-4024
Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL · Syrup · Oral · Xttrium Laboratories, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-4024-16 | 00116402416 | 473 mL in 1 BOTTLE, PLASTIC (0116-4024-16)Marketed from Apr 7, 2025 |
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)
- 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
- Syrup
- Route
- Oral
- Labeler
- Xttrium Laboratories, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088864
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0116-4024_30c9dc19-5091-17dd-e063-6394a90a51f9SPL ID 30c9dc19-5091-17dd-e063-6394a90a51f9SPL set ID 30c9d769-bc74-04d2-e063-6294a90a665aRxCUI 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
N400116402416followed by a unit qualifier and the quantityPackage 00116-4024-16. 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 Promethazine hydrochloride and dextromethorphan hydrobromide syrup 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 088864
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 | SyrupOral | Atlantic Biologicals Corp. | 17856-4024 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | A-S Medication Solutions | 50090-7658 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | A-S Medication Solutions | 50090-6467 |