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 SOLUTION
Routes
ORAL
Active Ingredients

risperidone 1 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-929
Product ID 62135-929_070bbc43-2f78-c14c-e063-6294a90a61f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202386
Listing Expiration 2026-12-31
Marketing Start 2015-01-12

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135929
Hyphenated Format 62135-929

Supplemental Identifiers

RxCUI
199387
UPC
0362135929435
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 ANDA202386 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (62135-929-43)
source: ndc

Packages (1)

62135-929-43 30 mL in 1 BOTTLE (62135-929-43)

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": "070bbc43-2f78-c14c-e063-6294a90a61f6", "openfda": {"nui": ["N0000175430"], "upc": ["0362135929435"], "unii": ["L6UH7ZF8HC"], "rxcui": ["199387"], "spl_set_id": ["66390528-7517-452a-ae76-4338ec7db3ae"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (62135-929-43)", "package_ndc": "62135-929-43", "marketing_start_date": "20220728"}], "brand_name": "RISPERIDONE", "product_id": "62135-929_070bbc43-2f78-c14c-e063-6294a90a61f6", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "62135-929", "generic_name": "RISPERIDONE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/mL"}], "application_number": "ANDA202386", "marketing_category": "ANDA", "marketing_start_date": "20150112", "listing_expiration_date": "20261231"}