What is NDC 67046-0644?

67046-0644 is the product NDC for Risperidone, Risperidone .5 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Risperidone?

168 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Risperidone NDC 67046-0644 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-0644Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-0644Add 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
67046-0644-3	6704606440367046064403	30 TABLET in 1 BLISTER PACK (67046-0644-3)Marketed from Jul 10, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Risperidone
Generic name (nonproprietary): risperidone
Active ingredients: Risperidone — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201003
Marketing start: Jul 10, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 67046-0644_5695b2ae-0e92-2f76-e063-6294a90a6c09SPL ID 5695b2ae-0e92-2f76-e063-6294a90a6c09SPL set ID 5643c32b-310e-4888-e063-6394a90ab62fRxCUI 312829UNII L6UH7ZF8HC
Pharmacologic class: Atypical Antipsychotic

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

N467046064403 followed by a unit qualifier and the quantity

Package 67046-0644-03. 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 Jul 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1) ] . 1.2 Bipolar Mania Monotherapy Risperidone tablets are indicated for the treatment of acute…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-0644

What is NDC 67046-0644?: 67046-0644 is the product NDC for Risperidone, Risperidone .5 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Risperidone.
What is the active ingredient?: Risperidone.
Who is the labeler?: Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Risperidone?: 168 other product NDCs are listed under this name. See all Risperidone 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 Risperidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-013	87564-0013-28
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-014	87564-0014-28
Risperidone	Risperidone 2 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-015	87564-0015-28
Risperidone	Risperidone 3 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-016	87564-0016-28
Risperidone	Risperidone 4 mg/1	Tablet, Orally disintegratingOral	Amerisyn LLC	87564-017	87564-0017-28
Risperidone	Risperidone .25 mg/1	TabletOral	Coupler LLC	67046-2064	67046-2064-03
Risperidone	Risperidone 1 mg/1	TabletOral	Coupler LLC	67046-0635	67046-0635-03
Risperidone	Risperidone 2 mg/1	TabletOral	Coupler LLC	67046-0630	67046-0630-03
Risperidone	Risperidone .5 mg/1	Tablet, Orally disintegratingOral	Amici Pharma, Inc.	69292-571	69292-0571-30
Risperidone	Risperidone 1 mg/1	Tablet, Orally disintegratingOral	Amici Pharma, Inc.	69292-572	69292-0572-28

All 169 Risperidone NDCs

Other NDCs under ANDA 201003

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

FDA NDC Directory listings under ANDA 201003
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone 1 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-001
Risperidone	Risperidone .25 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-002
Risperidone	Risperidone .5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-003
Risperidone	Risperidone 2 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-004
Risperidone	Risperidone 3 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-005
Risperidone	Risperidone 4 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-006
Risperidone	Risperidone 1 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-908
Risperidone	Risperidone 2 mg/1	TabletOral	A-S Medication Solutions	50090-3340
Risperidone	Risperidone 1 mg/1	TabletOral	A-S Medication Solutions	50090-3341
Risperidone	Risperidone .5 mg/1	TabletOral	A-S Medication Solutions	50090-3344
Risperidone	Risperidone 1 mg/1	TabletOral	Proficient Rx LP	63187-264
Risperidone	Risperidone 2 mg/1	TabletOral	Proficient Rx LP	63187-439
Risperidone	Risperidone .5 mg/1	TabletOral	Proficient Rx LP	63187-642
Risperidone	Risperidone 2 mg/1	TabletOral	Coupler LLC	67046-0630
Risperidone	Risperidone 1 mg/1	TabletOral	Coupler LLC	67046-0635
Risperidone	Risperidone 2 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4618
Risperidone	Risperidone 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-0364
Risperidone	Risperidone 3 mg/1	TabletOral	REMEDYREPACK INC.	70518-1502
Risperidone	Risperidone 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-1568
Risperidone	Risperidone .5 mg/1	TabletOral	REMEDYREPACK INC.	70518-1575

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