NDC codes

FDA NDC Directory
Product NDC (as listed)68084-270Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0270Add 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
68084-270-016808402700168084027001100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-270-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-270-11)Marketed from Dec 2, 2008

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, Film coated
Route
Oral
Labeler
American Health PackagingNDC labeler code 68084
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078040
Marketing start
Listing expires
Identifiers
Product ID 68084-270_43e5e95c-ad0c-3657-e063-6394a90af632SPL ID 43e5e95c-ad0c-3657-e063-6394a90af632SPL set ID f11dae15-b057-4258-9229-3819d0c980feRxCUI 312828, 312829, 312830, 312831, 312832, 314211UNII 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

N468084027001 followed by a unit qualifier and the quantity

Package 68084-0270-01. 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 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 associate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-270

What is NDC 68084-270?
68084-270 is the product NDC for Risperidone, Risperidone .25 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 68084. 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 078040

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

FDA NDC Directory listings under ANDA 078040
ProductStrengthForm · routeLabelerProduct NDC
risperidoneRisperidone .25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7360
risperidoneRisperidone .5 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7361
risperidoneRisperidone 1 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7362
risperidoneRisperidone 2 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7363
risperidoneRisperidone 3 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7364
risperidoneRisperidone 4 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7365
risperidoneRisperidone .5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0180
risperidoneRisperidone 1 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2634
risperidoneRisperidone .25 mg/1Tablet, Film coatedOralProficient Rx LP63187-418
risperidoneRisperidone .25 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-665
risperidoneRisperidone .5 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-666
risperidoneRisperidone 1 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-667
risperidoneRisperidone 2 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-668
risperidoneRisperidone 3 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-669
risperidoneRisperidone 4 mg/1Tablet, Film coatedOralZydus Lifesciences Limited65841-670
RisperidoneRisperidone .5 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-271
RisperidoneRisperidone 1 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-272
RisperidoneRisperidone 2 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-273
RisperidoneRisperidone 3 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-274
RisperidoneRisperidone 4 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-277

Showing 20 of 26.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in