Over-the-counter drug · ANDA
Dextromethorphan Polistirex NDC 58602-618
Dextromethorphan 30 mg/5mL · Suspension, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-618-05 | 5860206180558602061805 | 1 BOTTLE in 1 CARTON (58602-618-05) / 89 mL in 1 BOTTLEMarketed from Apr 17, 2026 | |
| 58602-618-06 | 5860206180658602061806 | 1 BOTTLE in 1 CARTON (58602-618-06) / 148 mL in 1 BOTTLEMarketed from Apr 17, 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 LLCNDC labeler code 58602
- 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 58602-618_1fc535f0-ed20-41b7-bd83-9e6fc36d831dSPL ID 1fc535f0-ed20-41b7-bd83-9e6fc36d831dSPL set ID fc328034-ad2a-4f7d-81cf-f4da4e64f5d7RxCUI 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
N458602061805followed by a unit qualifier and the quantityPackage 58602-0618-05. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 58602-618
- What is NDC 58602-618?
- 58602-618 is the product NDC for Dextromethorphan Polistirex, Dextromethorphan 30 mg/5mL suspension, extended release, listed with the FDA by Aurohealth LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextromethorphan Polistirex.
- What is the active ingredient?
- Dextromethorphan.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextromethorphan Polistirex?
- 4 other product NDCs are listed under this name. See all Dextromethorphan Polistirex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextromethorphan Polistirex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Target Corporation | 11673-033 | 11673-0033-05 |
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-617 | 58602-0617-0558602-0617-06 |
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-610 | 58602-0610-0558602-0610-06 |
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-611 | 58602-0611-0558602-0611-06 |
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 | Target Corporation | 11673-033 |
| Dextromethorphan Polistirex | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Aurohealth LLC | 58602-610 |
| 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 |