risperidone

Generic: risperidone

Labeler: natco pharma usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler natco pharma usa llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

risperidone .5 mg/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-182
Product ID 69339-182_856d65dc-f330-4195-b271-d0bdbe99519d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091537
Listing Expiration 2026-12-31
Marketing Start 2023-10-14

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69339182
Hyphenated Format 69339-182

Supplemental Identifiers

RxCUI
401953 401954 403825 616698 616705 645037
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 ANDA091537 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03)
source: ndc

Packages (1)

69339-182-03 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03)

Ingredients (1)

risperidone (.5 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": "856d65dc-f330-4195-b271-d0bdbe99519d", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["401953", "401954", "403825", "616698", "616705", "645037"], "spl_set_id": ["856d65dc-f330-4195-b271-d0bdbe99519d"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03)", "package_ndc": "69339-182-03", "marketing_start_date": "20231014"}], "brand_name": "Risperidone", "product_id": "69339-182_856d65dc-f330-4195-b271-d0bdbe99519d", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69339-182", "generic_name": "Risperidone", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": ".5 mg/1"}], "application_number": "ANDA091537", "marketing_category": "ANDA", "marketing_start_date": "20231014", "listing_expiration_date": "20261231"}