Prescription drug · ANDA
Risperidone NDC 68084-277
Risperidone 4 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-277-01 | 6808402770168084027701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-277-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-277-11)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 — 4 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 68084-277_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
N468084027701followed by a unit qualifier and the quantityPackage 68084-0277-01. 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.
About NDC 68084-277
- What is NDC 68084-277?
- 68084-277 is the product NDC for Risperidone, Risperidone 4 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.
Related NDCs: other Risperidone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Risperidone | Risperidone .5 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-013 | 87564-0013-28 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-014 | 87564-0014-28 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-015 | 87564-0015-28 |
| Risperidone | Risperidone 3 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-016 | 87564-0016-28 |
| Risperidone | Risperidone 4 mg/1 | Tablet, Orally disintegratingOral | Amerisyn LLC | 87564-017 | 87564-0017-28 |
| Risperidone | Risperidone .5 mg/1 | TabletOral | Coupler LLC | 67046-0644 | 67046-0644-03 |
| Risperidone | Risperidone .25 mg/1 | TabletOral | Coupler LLC | 67046-2064 | 67046-2064-03 |
| Risperidone | Risperidone 1 mg/1 | TabletOral | Coupler LLC | 67046-0635 | 67046-0635-03 |
| Risperidone | Risperidone 2 mg/1 | TabletOral | Coupler LLC | 67046-0630 | 67046-0630-03 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Orally disintegratingOral | Amici Pharma, Inc. | 69292-571 | 69292-0571-30 |
Other NDCs under ANDA 078040
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7360 |
| risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7361 |
| risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7362 |
| risperidone | Risperidone 2 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7363 |
| risperidone | Risperidone 3 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7364 |
| risperidone | Risperidone 4 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7365 |
| risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0180 |
| risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2634 |
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-418 |
| risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-665 |
| risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-666 |
| risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-667 |
| risperidone | Risperidone 2 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-668 |
| risperidone | Risperidone 3 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-669 |
| risperidone | Risperidone 4 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-670 |
| Risperidone | Risperidone .25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-270 |
| Risperidone | Risperidone .5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-271 |
| Risperidone | Risperidone 1 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-272 |
| Risperidone | Risperidone 2 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-273 |
| Risperidone | Risperidone 3 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-274 |
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