Prescription drug · ANDA
Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDC 17856-4024
Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL · Syrup · Oral · Atlantic Biologicals Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-4024-1 | 17856402401 | 72 CUP, UNIT-DOSE in 1 CASE (17856-4024-1) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Apr 24, 2026 |
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
- Syrup
- Route
- Oral
- Labeler
- Atlantic Biologicals Corp.
- 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 17856-4024_50223b67-c0bd-f577-e063-6394a90a8d8fSPL ID 50223b67-c0bd-f577-e063-6394a90a8d8fSPL set ID 5022379d-05ef-63f2-e063-6294a90a2189RxCUI 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
N417856402401followed by a unit qualifier and the quantityPackage 17856-4024-01. 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 | Xttrium Laboratories, Inc | 0116-4024 |
| 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 |