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 4 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-246
Product ID 71610-246_1ed35e98-e193-4975-917c-86bb64acf404
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 71610246
Hyphenated Format 71610-246

Supplemental Identifiers

RxCUI
314211
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
  • 4 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-246-15)
  • 30 TABLET in 1 BOTTLE (71610-246-30)
  • 45 TABLET in 1 BOTTLE (71610-246-45)
  • 60 TABLET in 1 BOTTLE (71610-246-53)
  • 90 TABLET in 1 BOTTLE (71610-246-60)
source: ndc

Packages (5)

71610-246-15 15 TABLET in 1 BOTTLE (71610-246-15) 71610-246-30 30 TABLET in 1 BOTTLE (71610-246-30) 71610-246-45 45 TABLET in 1 BOTTLE (71610-246-45) 71610-246-53 60 TABLET in 1 BOTTLE (71610-246-53) 71610-246-60 90 TABLET in 1 BOTTLE (71610-246-60)

Ingredients (1)

risperidone (4 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": "1ed35e98-e193-4975-917c-86bb64acf404", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["314211"], "spl_set_id": ["bda104ac-1eea-4a1a-836a-24bcc034b90f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-246-15)", "package_ndc": "71610-246-15", "marketing_start_date": "20190304"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-246-30)", "package_ndc": "71610-246-30", "marketing_start_date": "20190304"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-246-45)", "package_ndc": "71610-246-45", "marketing_start_date": "20190304"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-246-53)", "package_ndc": "71610-246-53", "marketing_start_date": "20190425"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-246-60)", "package_ndc": "71610-246-60", "marketing_start_date": "20190304"}], "brand_name": "RISPERIDONE", "product_id": "71610-246_1ed35e98-e193-4975-917c-86bb64acf404", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71610-246", "generic_name": "RISPERIDONE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "4 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20140328", "listing_expiration_date": "20261231"}