risperidone

Generic: risperidone

Labeler: janssen pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler janssen pharmaceutical, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

risperidone 1 mg/mL

Manufacturer
Janssen Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 50458-596
Product ID 50458-596_3b408b5f-285c-68a9-e063-6294a90ad609
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020588
Listing Expiration 2026-12-31
Marketing Start 1996-06-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458596
Hyphenated Format 50458-596

Supplemental Identifiers

RxCUI
199387 312829 312830 312831 312832 314211 401953 401954 403825 616698 616705
UNII
L6UH7ZF8HC
NUI
N0000175430

Packaging Origin

Original Packager
true

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 NDA020588 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (50458-596-01)
source: ndc

Packages (1)

50458-596-01 30 mL in 1 BOTTLE (50458-596-01)

Ingredients (1)

risperidone (1 mg/mL)

Linked Drug Pages (1)

Risperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b408b5f-285c-68a9-e063-6294a90ad609", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["199387", "312829", "312830", "312831", "312832", "314211", "401953", "401954", "403825", "616698", "616705"], "spl_set_id": ["701e1cd8-2868-4d29-85a9-a2212c88165f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Janssen Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (50458-596-01)", "package_ndc": "50458-596-01", "marketing_start_date": "19960610"}], "brand_name": "Risperidone", "product_id": "50458-596_3b408b5f-285c-68a9-e063-6294a90ad609", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-596", "generic_name": "risperidone", "labeler_name": "Janssen Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/mL"}], "application_number": "NDA020588", "marketing_category": "NDA", "marketing_start_date": "19960610", "listing_expiration_date": "20261231"}