risperidone

Generic: risperidone

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

risperidone 4 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-605
Product ID 62135-605_151f66f3-99b5-6d4d-e063-6394a90a1648
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077543
Listing Expiration 2026-12-31
Marketing Start 2011-05-18

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135605
Hyphenated Format 62135-605

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UPC
0362135605605 0362135601607 0362135604608 0362135603601 0362135600600 0362135602604
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 ANDA077543 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (62135-605-60)
source: ndc

Packages (1)

62135-605-60 60 TABLET, FILM COATED in 1 BOTTLE (62135-605-60)

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": "151f66f3-99b5-6d4d-e063-6394a90a1648", "openfda": {"nui": ["N0000175430"], "upc": ["0362135605605", "0362135601607", "0362135604608", "0362135603601", "0362135600600", "0362135602604"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["12a479c4-a84a-4308-b89f-be0315826fd5"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62135-605-60)", "package_ndc": "62135-605-60", "marketing_start_date": "20231229"}], "brand_name": "Risperidone", "product_id": "62135-605_151f66f3-99b5-6d4d-e063-6394a90a1648", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "62135-605", "generic_name": "Risperidone", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "4 mg/1"}], "application_number": "ANDA077543", "marketing_category": "ANDA", "marketing_start_date": "20110518", "listing_expiration_date": "20261231"}