risperidone

Generic: risperidone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

risperidone 1 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-167
Product ID 65862-167_95217dea-1f5b-4645-b55f-09a5d0e6960e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078452
Listing Expiration 2026-12-31
Marketing Start 2019-03-25

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862167
Hyphenated Format 65862-167

Supplemental Identifiers

RxCUI
199387
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 ANDA078452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-167-01) / 30 mL in 1 BOTTLE
  • 1 BOTTLE, GLASS in 1 CARTON (65862-167-30) / 30 mL in 1 BOTTLE, GLASS
source: ndc

Packages (2)

65862-167-01 1 BOTTLE in 1 CARTON (65862-167-01) / 30 mL in 1 BOTTLE 65862-167-30 1 BOTTLE, GLASS in 1 CARTON (65862-167-30) / 30 mL in 1 BOTTLE, GLASS

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": "95217dea-1f5b-4645-b55f-09a5d0e6960e", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["199387"], "spl_set_id": ["c4582bdf-5eda-438c-98b4-0517500501e8"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-167-01)  / 30 mL in 1 BOTTLE", "package_ndc": "65862-167-01", "marketing_start_date": "20190325"}, {"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (65862-167-30)  / 30 mL in 1 BOTTLE, GLASS", "package_ndc": "65862-167-30", "marketing_start_date": "20190325"}], "brand_name": "RISPERIDONE", "product_id": "65862-167_95217dea-1f5b-4645-b55f-09a5d0e6960e", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-167", "generic_name": "RISPERIDONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/mL"}], "application_number": "ANDA078452", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20261231"}