NDC codes

FDA NDC Directory
Product NDC (as listed)71205-520Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0520Add 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
71205-520-30712050520307120505203030 TABLET in 1 BOTTLE (71205-520-30)Marketed from Jan 5, 2021
71205-520-60712050520607120505206060 TABLET in 1 BOTTLE (71205-520-60)Marketed from Jan 5, 2021
71205-520-90712050520907120505209090 TABLET in 1 BOTTLE (71205-520-90)Marketed from Jan 5, 2021

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 — .25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201003
Marketing start
Listing expires
Identifiers
Product ID 71205-520_be1f8d5f-876a-4c16-b504-8812d781e06dSPL ID be1f8d5f-876a-4c16-b504-8812d781e06dSPL set ID 394c7e27-52a2-4d4c-8c6e-fe37b03266aeRxCUI 312828UNII L6UH7ZF8HCUPC 0371205520304
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

N471205052030 followed by a unit qualifier and the quantity

Package 71205-0520-30. 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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-520

What is NDC 71205-520?
71205-520 is the product NDC for Risperidone, Risperidone .25 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, 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?
Proficient Rx LP, NDC labeler code 71205. 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

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
ProductStrengthForm · routeLabelerProduct NDC
RisperidoneRisperidone 1 mg/1TabletOralAjanta Pharma USA Inc.27241-001
RisperidoneRisperidone .25 mg/1TabletOralAjanta Pharma USA Inc.27241-002
RisperidoneRisperidone .5 mg/1TabletOralAjanta Pharma USA Inc.27241-003
RisperidoneRisperidone 2 mg/1TabletOralAjanta Pharma USA Inc.27241-004
RisperidoneRisperidone 3 mg/1TabletOralAjanta Pharma USA Inc.27241-005
RisperidoneRisperidone 4 mg/1TabletOralAjanta Pharma USA Inc.27241-006
RisperidoneRisperidone 1 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-908
RisperidoneRisperidone 2 mg/1TabletOralA-S Medication Solutions50090-3340
RisperidoneRisperidone 1 mg/1TabletOralA-S Medication Solutions50090-3341
RisperidoneRisperidone .5 mg/1TabletOralA-S Medication Solutions50090-3344
RisperidoneRisperidone 1 mg/1TabletOralProficient Rx LP63187-264
RisperidoneRisperidone 2 mg/1TabletOralProficient Rx LP63187-439
RisperidoneRisperidone .5 mg/1TabletOralProficient Rx LP63187-642
RisperidoneRisperidone 2 mg/1TabletOralCoupler LLC67046-0630
RisperidoneRisperidone 1 mg/1TabletOralCoupler LLC67046-0635
RisperidoneRisperidone .5 mg/1TabletOralCoupler LLC67046-0644
RisperidoneRisperidone 2 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4618
RisperidoneRisperidone 1 mg/1TabletOralREMEDYREPACK INC.70518-0364
RisperidoneRisperidone 3 mg/1TabletOralREMEDYREPACK INC.70518-1502
RisperidoneRisperidone 2 mg/1TabletOralREMEDYREPACK INC.70518-1568

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