What is NDC 62135-604?

62135-604 is the product NDC for Risperidone, Risperidone 3 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Chartwell RX, LLC, NDC labeler code 62135. 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 62135-604 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-604Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0604Add 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
62135-604-60	6213506046062135060460	60 TABLET, FILM COATED in 1 BOTTLE (62135-604-60)Marketed from Dec 29, 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): Risperidone
Generic name (nonproprietary): risperidone
Active ingredients: Risperidone — 3 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Chartwell RX, LLCNDC labeler code 62135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077543
Marketing start: May 18, 2011
Listing expires: Dec 31, 2026
Identifiers: Product ID 62135-604_151f66f3-99b5-6d4d-e063-6394a90a1648SPL ID 151f66f3-99b5-6d4d-e063-6394a90a1648SPL set ID 12a479c4-a84a-4308-b89f-be0315826fd5RxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII L6UH7ZF8HCUPC 0362135605605, 0362135601607, 0362135604608, 0362135603601, 0362135600600, 0362135602604
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

N462135060460 followed by a unit qualifier and the quantity

Package 62135-0604-60. 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 Apr 2, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone is 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 is 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 is indicated for the treatment of acute manic or mixed episodes as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-604

What is NDC 62135-604?: 62135-604 is the product NDC for Risperidone, Risperidone 3 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, 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?: Chartwell RX, LLC, NDC labeler code 62135. 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 .5 mg/1	TabletOral	Coupler LLC	67046-0644	67046-0644-03
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

All 169 Risperidone NDCs

Other NDCs under ANDA 077543

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

FDA NDC Directory listings under ANDA 077543
Product	Strength	Form · route	Labeler	Product NDC
Risperidone	Risperidone .25 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-600
Risperidone	Risperidone .5 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-601
Risperidone	Risperidone 1 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-602
Risperidone	Risperidone 2 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-603
Risperidone	Risperidone 4 mg/1	Tablet, Film coatedOral	Chartwell RX, LLC	62135-605