risperidone

Generic: risperidone

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

risperidone 1 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-981
Product ID 62559-981_2c44590a-6811-49fb-8cef-de7dc5bc6164
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076440
Listing Expiration 2027-12-31
Marketing Start 2025-10-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559981
Hyphenated Format 62559-981

Supplemental Identifiers

RxCUI
199387
UPC
0362559981309
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 ANDA076440 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (62559-981-30)
source: ndc

Packages (1)

62559-981-30 30 mL in 1 BOTTLE (62559-981-30)

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": "2c44590a-6811-49fb-8cef-de7dc5bc6164", "openfda": {"nui": ["N0000175430"], "upc": ["0362559981309"], "unii": ["L6UH7ZF8HC"], "rxcui": ["199387"], "spl_set_id": ["1f47ec91-602f-4fba-8f7e-a5698760b655"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (62559-981-30)", "package_ndc": "62559-981-30", "marketing_start_date": "20251027"}], "brand_name": "Risperidone", "product_id": "62559-981_2c44590a-6811-49fb-8cef-de7dc5bc6164", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "62559-981", "generic_name": "Risperidone", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/mL"}], "application_number": "ANDA076440", "marketing_category": "ANDA", "marketing_start_date": "20251027", "listing_expiration_date": "20271231"}