risperidone

Generic: risperidone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-264
Product ID 71610-264_734267df-c692-446a-ae8b-47462213b1ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201003
Listing Expiration 2026-12-31
Marketing Start 2014-03-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610264
Hyphenated Format 71610-264

Supplemental Identifiers

RxCUI
312831
UNII
L6UH7ZF8HC
NUI
N0000175430

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name risperidone (source: ndc)
Generic Name risperidone (source: ndc)
Application Number ANDA201003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-264-15)
  • 30 TABLET in 1 BOTTLE (71610-264-30)
  • 45 TABLET in 1 BOTTLE (71610-264-45)
source: ndc

Packages (3)

71610-264-15 15 TABLET in 1 BOTTLE (71610-264-15) 71610-264-30 30 TABLET in 1 BOTTLE (71610-264-30) 71610-264-45 45 TABLET in 1 BOTTLE (71610-264-45)

Ingredients (1)

risperidone (2 mg/1)

Linked Drug Pages (1)

RISPERIDONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "734267df-c692-446a-ae8b-47462213b1ba", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312831"], "spl_set_id": ["ac152803-d75f-4c3c-bc49-8663b21a3a82"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-264-15)", "package_ndc": "71610-264-15", "marketing_start_date": "20190425"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-264-30)", "package_ndc": "71610-264-30", "marketing_start_date": "20190425"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-264-45)", "package_ndc": "71610-264-45", "marketing_start_date": "20190425"}], "brand_name": "RISPERIDONE", "product_id": "71610-264_734267df-c692-446a-ae8b-47462213b1ba", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71610-264", "generic_name": "RISPERIDONE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20140328", "listing_expiration_date": "20261231"}