risperdal

Generic: risperidone

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

Drug Facts

Product Profile

Brand Name risperdal
Generic Name risperidone
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 4 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-350
Product ID 50458-350_43556c05-69ec-1276-e063-6294a90a968e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020272
Listing Expiration 2026-12-31
Marketing Start 1993-12-29

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458350
Hyphenated Format 50458-350

Supplemental Identifiers

RxCUI
104781 104782 104783 104784 199387 211489 262222 312829 312830 312831 312832 314211 401953 401954 403825 616698 616705 630890 630974 806297 806298 806299
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 risperdal (source: ndc)
Generic Name risperidone (source: ndc)
Application Number NDA020272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-350-01) / 10 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (50458-350-06)
source: ndc

Packages (2)

50458-350-01 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-350-01) / 10 TABLET in 1 BLISTER PACK 50458-350-06 60 TABLET in 1 BOTTLE (50458-350-06)

Ingredients (1)

risperidone (4 mg/1)

Linked Drug Pages (1)

RISPERDAL, RISPERDAL M-TAB ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43556c05-69ec-1276-e063-6294a90a968e", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["104781", "104782", "104783", "104784", "199387", "211489", "262222", "312829", "312830", "312831", "312832", "314211", "401953", "401954", "403825", "616698", "616705", "630890", "630974", "806297", "806298", "806299"], "spl_set_id": ["7e117c7e-02fc-4343-92a1-230061dfc5e0"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-350-01)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "50458-350-01", "marketing_start_date": "19931229"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50458-350-06)", "package_ndc": "50458-350-06", "marketing_start_date": "19931229"}], "brand_name": "RISPERDAL", "product_id": "50458-350_43556c05-69ec-1276-e063-6294a90a968e", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-350", "generic_name": "risperidone", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERDAL", "active_ingredients": [{"name": "RISPERIDONE", "strength": "4 mg/1"}], "application_number": "NDA020272", "marketing_category": "NDA", "marketing_start_date": "19931229", "listing_expiration_date": "20261231"}