NDC codes

FDA NDC Directory
Product NDC (as listed)43547-340Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0340Add 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
43547-340-064354703400660 TABLET in 1 BOTTLE (43547-340-06)Marketed from Jun 1, 2014
43547-340-5043547034050500 TABLET in 1 BOTTLE (43547-340-50)Marketed from Jun 1, 2014

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 — .5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077493
Marketing start
Listing expires
Identifiers
Product ID 43547-340_96d2f276-6bf9-4dfd-8831-888ca0c5c5b0SPL ID 96d2f276-6bf9-4dfd-8831-888ca0c5c5b0SPL set ID 43aa2a4f-1123-4f86-800b-9218882f7bcdRxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII L6UH7ZF8HCUPC 0343547343064, 0343547344061, 0343547342067, 0343547340063, 0343547339067, 0343547341060
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

N443547034006 followed by a unit qualifier and the quantity

Package 43547-0340-06. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 077493

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

FDA NDC Directory listings under ANDA 077493
ProductStrengthForm · routeLabelerProduct NDC
RisperidoneRisperidone .25 mg/1TabletOralCoupler LLC67046-2064
RisperidoneRisperidone 2 mg/1TabletOralBryant Ranch Prepack71335-2645
RisperidoneRisperidone 1 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3873
RisperidoneRisperidone .25 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8196
RisperidoneRisperidone 1 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8198
RisperidoneRisperidone 1 mg/1TabletOralREMEDYREPACK INC.70518-3883
RisperidoneRisperidone 2 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8288
RisperidoneRisperidone .5 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8197
RisperidoneRisperidone 3 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8265
RisperidoneRisperidone 2 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-259
RisperidoneRisperidone .25 mg/1TabletOralSolco Healthcare US, LLC43547-339
RisperidoneRisperidone 4 mg/1TabletOralSolco Healthcare US, LLC43547-344
RisperidoneRisperidone 1 mg/1TabletOralSolco Healthcare US, LLC43547-341
RisperidoneRisperidone 2 mg/1TabletOralSolco Healthcare US, LLC43547-342
RisperidoneRisperidone 3 mg/1TabletOralSolco Healthcare US, LLC43547-343
RisperidoneRisperidone 3 mg/1TabletOralREMEDYREPACK INC.70518-4426
RisperidoneRisperidone 2 mg/1TabletOralREMEDYREPACK INC.70518-4431

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