Prescription drug · ANDA
Dextromethorphan Hydrobromide and Quinidine Sulphate NDC 63304-650
Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-650-60 | 63304065060 | 60 CAPSULE in 1 BOTTLE (63304-650-60)Marketed from Jul 30, 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 Hydrobromide and Quinidine Sulphate
- Generic name (nonproprietary)
- dextromethorphan hydrobromide and quinidine sulphate
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/1Quinidine sulfate — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204196
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63304-650_5617af8d-e7b7-1c2c-e063-6294a90a7486SPL ID 5617af8d-e7b7-1c2c-e063-6294a90a7486SPL set ID 92b54ac4-594e-47b8-a4d3-394a29b425f3RxCUI 1040054UNII 9D2RTI9KYH, J13S2394HEUPC 0363304650600
- Pharmacologic class
- Antiarrhythmic; Cytochrome P450 2D6 Inhibitor; 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
N463304065060followed by a unit qualifier and the quantityPackage 63304-0650-60. 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)
Dextromethorphan hydrobromide and quinidine sulfate capsules are indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury. Dextromethorphan hydrobromide and quinidine sulfate capsules is a combination product containing dextromethorphan hydrobromide (an uncompetitive NMDA receptor antago…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204196
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 Hydrobromide and Quinidine Sulphate | Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 84677-067 |