NDC codes

FDA NDC Directory
Product NDC (as listed)83745-186Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83745-0186Add 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 NDC11-digit (billing)PackageCopy
83745-186-30837450186308374501863030 mL in 1 BOTTLE (83745-186-30)Marketed from Jan 31, 2025

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 — 1 mg/mL
Dosage form
Solution
Route
Oral
Labeler
APOZEAL PHARMACEUTICALS INCNDC labeler code 83745
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078909
Marketing start
Listing expires
Identifiers
Product ID 83745-186_38eb3e14-7f79-42c8-ac58-2c050c6295a8SPL ID 38eb3e14-7f79-42c8-ac58-2c050c6295a8SPL set ID 4ab6d256-6590-45be-a5df-f505987f96c3RxCUI 199387UNII 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

N483745018630 followed by a unit qualifier and the quantity

Package 83745-0186-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Risperidone is an atypical antipsychotic agent 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 oral solution 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 oral solution is indicated for the treatment of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83745-186

What is NDC 83745-186?
83745-186 is the product NDC for Risperidone, Risperidone 1 mg/mL solution, listed with the FDA by APOZEAL PHARMACEUTICALS INC. 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?
APOZEAL PHARMACEUTICALS INC, NDC labeler code 83745. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RisperidoneRisperidone .5 mg/1Tablet, Orally disintegratingOralAmerisyn LLC87564-01387564-0013-28
RisperidoneRisperidone 1 mg/1Tablet, Orally disintegratingOralAmerisyn LLC87564-01487564-0014-28
RisperidoneRisperidone 2 mg/1Tablet, Orally disintegratingOralAmerisyn LLC87564-01587564-0015-28
RisperidoneRisperidone 3 mg/1Tablet, Orally disintegratingOralAmerisyn LLC87564-01687564-0016-28
RisperidoneRisperidone 4 mg/1Tablet, Orally disintegratingOralAmerisyn LLC87564-01787564-0017-28
RisperidoneRisperidone .5 mg/1TabletOralCoupler LLC67046-064467046-0644-03
RisperidoneRisperidone .25 mg/1TabletOralCoupler LLC67046-206467046-2064-03
RisperidoneRisperidone 1 mg/1TabletOralCoupler LLC67046-063567046-0635-03
RisperidoneRisperidone 2 mg/1TabletOralCoupler LLC67046-063067046-0630-03
RisperidoneRisperidone .5 mg/1Tablet, Orally disintegratingOralAmici Pharma, Inc.69292-57169292-0571-30

All 169 Risperidone NDCs

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