What is NDC 59148-053?

59148-053 is the product NDC for Nuedexta, Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 capsule, gelatin coated, listed with the FDA by Otsuka America Pharmaceutical, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Nuedexta (Dextromethorphan hydrobromide and quinidine sulfate).

What is the active ingredient?

Dextromethorphan hydrobromide, Quinidine sulfate.

Otsuka America Pharmaceutical, Inc, NDC labeler code 59148. 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 59148-053 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59148-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59148-0053Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59148-053-16	59148005316	60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)Marketed from Jan 3, 2023
59148-053-98	59148005398	4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Jan 3, 2023

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): 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: Otsuka America Pharmaceutical, IncNDC labeler code 59148
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021879
Marketing start: Jan 3, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abaeSPL ID b73848d5-ceb2-482a-99bd-a2b6b895abaeSPL set ID c8cce784-8c5f-415b-8068-76e5d481d159RxCUI 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.

NDC on a medical claim

N459148005316 followed by a unit qualifier and the quantity

Package 59148-0053-16. 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 Jan 22, 2026.

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 59148-053

What is NDC 59148-053?: 59148-053 is the product NDC for Nuedexta, Dextromethorphan hydrobromide 20 mg/1; Quinidine sulfate 10 mg/1 capsule, gelatin coated, listed with the FDA by Otsuka America Pharmaceutical, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
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?: Otsuka America Pharmaceutical, Inc, NDC labeler code 59148. 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	Avanir Pharmaceuticals, Inc.	64597-301	—

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	Avanir Pharmaceuticals, Inc.	64597-301