NDC codes

FDA NDC Directory
Product NDC (as listed)27808-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0002Add 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
27808-002-01278080002012780800020130 mL in 1 BOTTLE, UNIT-DOSE (27808-002-01)Marketed from Mar 13, 2015

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
Cranbury Pharmaceuticals, LLCNDC labeler code 27808
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079059
Marketing start
Listing expires
Identifiers
Product ID 27808-002_0cc8cb14-5af8-475e-add9-f6cd3e9d7a38SPL ID 0cc8cb14-5af8-475e-add9-f6cd3e9d7a38SPL set ID a0a21bec-68f0-444e-a611-d0602859410cRxCUI 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

N427808000201 followed by a unit qualifier and the quantity

Package 27808-0002-01. 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 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 acut…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27808-002

What is NDC 27808-002?
27808-002 is the product NDC for Risperidone, Risperidone 1 mg/mL solution, listed with the FDA by Cranbury Pharmaceuticals, 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?
Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. 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 079059

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

FDA NDC Directory listings under ANDA 079059
ProductStrengthForm · routeLabelerProduct NDC
RisperidoneRisperidone 1 mg/mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-1002
RisperidoneRisperidone 1 mg/mLSolutionOralREMEDYREPACK INC.70518-3741
RisperidoneRisperidone 1 mg/mLSolutionOralBryant Ranch Prepack71335-2733
RisperidoneRisperidone 1 mg/mLSolutionOralBryant Ranch Prepack72162-2037

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