risperidone

Generic: risperidone

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2111
Product ID 69238-2111_a852094f-1084-4916-a185-e7ea35080780
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078071
Listing Expiration 2026-12-31
Marketing Start 2021-08-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382111
Hyphenated Format 69238-2111

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UPC
0369238210866 0369238211061 0369238211269 0369238211160 0369238211368 0369238210965
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 ANDA078071 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (69238-2111-5)
  • 60 TABLET in 1 BOTTLE (69238-2111-6)
source: ndc

Packages (2)

69238-2111-5 500 TABLET in 1 BOTTLE (69238-2111-5) 69238-2111-6 60 TABLET in 1 BOTTLE (69238-2111-6)

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": "a852094f-1084-4916-a185-e7ea35080780", "openfda": {"nui": ["N0000175430"], "upc": ["0369238210866", "0369238211061", "0369238211269", "0369238211160", "0369238211368", "0369238210965"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["e90c886c-132a-4df6-8604-cfe5ffa49d5b"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (69238-2111-5)", "package_ndc": "69238-2111-5", "marketing_start_date": "20210801"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (69238-2111-6)", "package_ndc": "69238-2111-6", "marketing_start_date": "20210801"}], "brand_name": "Risperidone", "product_id": "69238-2111_a852094f-1084-4916-a185-e7ea35080780", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69238-2111", "generic_name": "Risperidone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA078071", "marketing_category": "ANDA", "marketing_start_date": "20210801", "listing_expiration_date": "20261231"}