What is NDC 64597-301?

64597-301 is the product NDC for Nuedexta, Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 capsule, gelatin coated, listed with the FDA by Avanir Pharmaceuticals, Inc..

What drug is associated with this NDC?

Nuedexta (Dextromethorphan hydrobromide and quinidine sulfate).

What is the active ingredient?

Dextromethorphan hydrobromide, Quinidine sulfate.

Avanir Pharmaceuticals, Inc., NDC labeler code 64597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nuedexta?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nuedexta NDC 64597-301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64597-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64597-0301Add the package segment from the table below.

Product information

Brand name (proprietary): Nuedexta
Generic name (nonproprietary): dextromethorphan hydrobromide and quinidine sulfate
Active ingredients: Dextromethorphan hydrobromide — 20 mg/1Quinidine sulfate — 10 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Avanir Pharmaceuticals, Inc.NDC labeler code 64597
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021879
Marketing start: Dec 1, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 64597-301_545d121c-01b2-4375-9067-52fc8ad23d74SPL ID 545d121c-01b2-4375-9067-52fc8ad23d74SPL set ID 484e0918-3442-49dc-8ccf-177f1f3ee9f3RxCUI 1040054, 1040058UNII 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.

Product label

Current FDA label (SPL), effective Oct 21, 2025.

Indications (excerpt from the label)

NUEDEXTA is 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. NUEDEXTA is a combination product containing dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) indicated for the treatment of p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64597-301

What is NDC 64597-301?: 64597-301 is the product NDC for Nuedexta, Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 capsule, gelatin coated, listed with the FDA by Avanir Pharmaceuticals, Inc..
What drug is associated with this NDC?: Nuedexta (Dextromethorphan hydrobromide and quinidine sulfate).
What is the active ingredient?: Dextromethorphan hydrobromide, Quinidine sulfate.
Who is the labeler?: Avanir Pharmaceuticals, Inc., NDC labeler code 64597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nuedexta?: 1 other product NDC are listed under this name. See all Nuedexta NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nuedexta NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nuedextadextromethorphan hydrobromide and quinidine sulfate	Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1	Capsule, Gelatin coatedOral	Otsuka America Pharmaceutical, Inc	59148-053	59148-0053-1659148-0053-98

Other NDCs under NDA 021879

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021879
Product	Strength	Form · route	Labeler	Product NDC
Nuedextadextromethorphan hydrobromide and quinidine sulfate	Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1	Capsule, Gelatin coatedOral	Otsuka America Pharmaceutical, Inc	59148-053