risperdal consta

Generic: risperidone

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperdal consta
Generic Name risperidone
Labeler janssen pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-307
Product ID 50458-307_42dc490b-4117-142a-e063-6294a90aeb21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021346
Listing Expiration 2026-12-31
Marketing Start 2003-10-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458307
Hyphenated Format 50458-307

Supplemental Identifiers

RxCUI
402010 402011 402012 706822 706825 706827 706829 706831

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 risperdal consta (source: ndc)
Generic Name risperidone (source: ndc)
Application Number NDA021346 (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 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-307-01)
source: ndc

Packages (1)

50458-307-11 1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-307-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

RISPERDAL CONSTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "42dc490b-4117-142a-e063-6294a90aeb21", "openfda": {"rxcui": ["402010", "402011", "402012", "706822", "706825", "706827", "706829", "706831"], "spl_set_id": ["bb34ee82-d2c2-43b8-ba21-2825c0954691"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 BOX (50458-307-11)  *  2 mL in 1 VIAL *  2 mL in 1 SYRINGE (50458-307-01)", "package_ndc": "50458-307-11", "marketing_start_date": "20031029"}], "brand_name": "RISPERDAL CONSTA", "product_id": "50458-307_42dc490b-4117-142a-e063-6294a90aeb21", "dosage_form": "KIT", "product_ndc": "50458-307", "generic_name": "risperidone", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERDAL CONSTA", "application_number": "NDA021346", "marketing_category": "NDA", "marketing_start_date": "20031029", "listing_expiration_date": "20261231"}