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 71610-259
Product ID 71610-259_d100ecbc-bf31-4407-a2d6-203a429375c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077493
Listing Expiration 2026-12-31
Marketing Start 2015-06-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610259
Hyphenated Format 71610-259

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 ANDA077493 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-259-15)
  • 30 TABLET in 1 BOTTLE (71610-259-30)
  • 45 TABLET in 1 BOTTLE (71610-259-45)
source: ndc

Packages (3)

71610-259-15 15 TABLET in 1 BOTTLE (71610-259-15) 71610-259-30 30 TABLET in 1 BOTTLE (71610-259-30) 71610-259-45 45 TABLET in 1 BOTTLE (71610-259-45)

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": "d100ecbc-bf31-4407-a2d6-203a429375c2", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312831"], "spl_set_id": ["58e422ec-da66-41b0-83c1-aefd940beda0"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-259-15)", "package_ndc": "71610-259-15", "marketing_start_date": "20190403"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-259-30)", "package_ndc": "71610-259-30", "marketing_start_date": "20190403"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-259-45)", "package_ndc": "71610-259-45", "marketing_start_date": "20190403"}], "brand_name": "Risperidone", "product_id": "71610-259_d100ecbc-bf31-4407-a2d6-203a429375c2", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71610-259", "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": "ANDA077493", "marketing_category": "ANDA", "marketing_start_date": "20150601", "listing_expiration_date": "20261231"}