risperidone

Generic: risperidone

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler amneal pharmaceuticals llc
Dosage Form KIT
Routes
INTRAMUSCULAR
Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-2627
Product ID 70121-2627_1109da94-12c2-4378-b9fb-74f94382b90a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218586
Listing Expiration 2026-12-31
Marketing Start 2025-09-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701212627
Hyphenated Format 70121-2627

Supplemental Identifiers

RxCUI
402010 402011 402012 706822
UPC
0370121262756 0370121262855 0370121262558 0370121262428

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 ANDA218586 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 12.5 mg
  • 25 mg
  • 37.5 mg
  • 50 mg
  • 2 ml
  • 21 g
  • 20 g
  • 41 mg
  • 78 mg
  • 116 mg
  • 152 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (70121-2627-5) * 2 mL in 1 VIAL (70121-1352-1) * 2 mL in 1 SYRINGE (70121-2624-2)
source: ndc

Packages (1)

70121-2627-5 1 KIT in 1 CARTON (70121-2627-5) * 2 mL in 1 VIAL (70121-1352-1) * 2 mL in 1 SYRINGE (70121-2624-2)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Risperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "1109da94-12c2-4378-b9fb-74f94382b90a", "openfda": {"upc": ["0370121262756", "0370121262855", "0370121262558", "0370121262428"], "rxcui": ["402010", "402011", "402012", "706822"], "spl_set_id": ["d526af85-ee70-4657-a27e-d451027ffd9e"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (70121-2627-5)  *  2 mL in 1 VIAL (70121-1352-1)  *  2 mL in 1 SYRINGE (70121-2624-2)", "package_ndc": "70121-2627-5", "marketing_start_date": "20250908"}], "brand_name": "Risperidone", "product_id": "70121-2627_1109da94-12c2-4378-b9fb-74f94382b90a", "dosage_form": "KIT", "product_ndc": "70121-2627", "generic_name": "risperidone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "application_number": "ANDA218586", "marketing_category": "ANDA", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}