risperidone

Generic: risperidone

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler remedyrepack inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

risperidone 1 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3741
Product ID 70518-3741_3f647674-e242-a4f6-e063-6394a90a390b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079059
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183741
Hyphenated Format 70518-3741

Supplemental Identifiers

RxCUI
199387
UNII
L6UH7ZF8HC
NUI
N0000175430

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 ANDA079059 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 BOX (70518-3741-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3741-1)
source: ndc

Packages (1)

70518-3741-0 10 CUP, UNIT-DOSE in 1 BOX (70518-3741-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3741-1)

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": "3f647674-e242-a4f6-e063-6394a90a390b", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["199387"], "spl_set_id": ["8a4158fe-37d4-4c97-9c44-1c3489fe2a9f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 BOX (70518-3741-0)  / 2 mL in 1 CUP, UNIT-DOSE (70518-3741-1)", "package_ndc": "70518-3741-0", "marketing_start_date": "20230601"}], "brand_name": "Risperidone", "product_id": "70518-3741_3f647674-e242-a4f6-e063-6394a90a390b", "dosage_form": "SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-3741", "generic_name": "Risperidone", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "1 mg/mL"}], "application_number": "ANDA079059", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}