Over-the-counter drug · NDA
Delsym (Dextromethorphan) NDC 63824-175
Dextromethorphan 30 mg/5mL · Suspension, Extended release · Oral · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63824-175-22 | 63824017522 | 2 CARTON in 1 CELLO PACK (63824-175-22) / 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLEMarketed from May 4, 2010 | |
| 63824-175-63 | 63824017563 | 1 BOTTLE in 1 CARTON (63824-175-63) / 89 mL in 1 BOTTLEMarketed from May 4, 2010 | |
| 63824-175-65 | 63824017565 | 1 BOTTLE in 1 CARTON (63824-175-65) / 148 mL in 1 BOTTLEMarketed from May 4, 2010 |
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)
- Delsym
- Generic name (nonproprietary)
- dextromethorphan
- Active ingredients
- Dextromethorphan — 30 mg/5mL
- Dosage form
- Suspension, Extended release
- Route
- Oral
- Labeler
- Reckitt Benckiser LLCNDC labeler code 63824
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018658
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63824-175_5b143305-ab62-63e0-e063-6294a90aed7dSPL ID 5b143305-ab62-63e0-e063-6294a90aed7dSPL set ID e3e1d126-76c2-4776-8ce0-449625b7e6baRxCUI 1373045, 1373128UNII 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
N463824017522followed by a unit qualifier and the quantityPackage 63824-0175-22. 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 63824-175
- What is NDC 63824-175?
- 63824-175 is the product NDC for Delsym (dextromethorphan), Dextromethorphan 30 mg/5mL suspension, extended release, listed with the FDA by Reckitt Benckiser LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Delsym (Dextromethorphan).
- What is the active ingredient?
- Dextromethorphan.
- Who is the labeler?
- Reckitt Benckiser LLC, NDC labeler code 63824. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Delsym?
- 2 other product NDCs are listed under this name. See all Delsym NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Delsym products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Delsymdextromethorphan | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | A-S Medication Solutions | 50090-0224 | 50090-0224-00 |
| Delsymdextromethorphan | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Reckitt Benckiser LLC | 63824-171 | 63824-0171-2263824-0171-6363824-0171-65+1 more |
Other NDCs under NDA 018658
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 |
|---|---|---|---|---|
| Delsymdextromethorphan | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | A-S Medication Solutions | 50090-0224 |
| Delsymdextromethorphan | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Reckitt Benckiser LLC | 63824-171 |
| Delsym (Dextromethorphan)dextromethorphan | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Reckitt Benckiser LLC | 63824-173 |
| Delsym (Dextromethorphan)dextromethorphan | Dextromethorphan 30 mg/5mL | Suspension, Extended releaseOral | Reckitt Benckiser LLC | 63824-177 |