Over-the-counter drug · ANDA
Dextromethorphan Polistirex NDC 58602-610
Dextromethorphan 30 mg/5mL · Suspension, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-610-05 | 58602061005 | 1 BOTTLE in 1 CARTON (58602-610-05) / 89 mL in 1 BOTTLEMarketed from Apr 15, 2026 | |
| 58602-610-06 | 58602061006 | 1 BOTTLE in 1 CARTON (58602-610-06) / 148 mL in 1 BOTTLEMarketed from Apr 15, 2026 |
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)
- Dextromethorphan Polistirex
- Generic name (nonproprietary)
- dextromethorphan polistirex
- Active ingredients
- Dextromethorphan — 30 mg/5mL
- Dosage form
- Suspension, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218417
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 58602-610_126b5a4d-b915-4fe8-9156-a94d729ac47dSPL ID 126b5a4d-b915-4fe8-9156-a94d729ac47dSPL set ID 4fde00af-3824-44f1-8a5f-d88518e0a8c8RxCUI 1373045UNII 7355X3ROTS
- Pharmacologic class
- 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
N458602061005followed by a unit qualifier and the quantityPackage 58602-0610-05. 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.
Other NDCs under ANDA 218417
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 |
|---|---|---|---|---|
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-611 |
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-617 |
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-618 |