Prescription drug · ANDA
Dextromethorphan hydrobromide and quinidine sulfate NDC 31722-693
Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-693-60 | 31722069360 | 60 CAPSULE in 1 BOTTLE (31722-693-60)Marketed from Aug 28, 2024 |
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 sulfate
- Generic name (nonproprietary)
- dextromethorphan hydrobromide and quinidine sulfate
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/1Quinidine sulfate — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218426
- 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 31722-693_2d3a1851-0309-c3a1-e063-6294a90abd14SPL ID 2d3a1851-0309-c3a1-e063-6294a90abd14SPL set ID 7028dcb7-f436-4cf6-9beb-23c1d215c798RxCUI 1040054UNII 9D2RTI9KYH, J13S2394HE
- 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
N431722069360followed by a unit qualifier and the quantityPackage 31722-0693-60. 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 are a combination product containing dextromethorphan hydrobromide (an uncompetitive NMDA receptor antag…
Excerpt only. Read the full label for complete information.
About NDC 31722-693
- What is NDC 31722-693?
- 31722-693 is the product NDC for Dextromethorphan hydrobromide and quinidine sulfate, Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 capsule, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextromethorphan hydrobromide and quinidine sulfate.
- What is the active ingredient?
- Dextromethorphan hydrobromide, Quinidine sulfate.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 hydrobromide and quinidine sulfate?
- 1 other product NDC are listed under this name. See all Dextromethorphan hydrobromide and quinidine sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextromethorphan hydrobromide and quinidine sulfate 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 hydrobromide and quinidine sulfate | Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-2602 | 00480-2602-06 |