risperidone

Generic: risperidone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

risperidone 3 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-643
Product ID 63304-643_8c155c45-e5c8-4358-90da-8f6d193ad88b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078474
Listing Expiration 2026-12-31
Marketing Start 2010-08-06

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304643
Hyphenated Format 63304-643

Supplemental Identifiers

RxCUI
401953 401954 403825 616698 616705
UPC
0363304949308
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 ANDA078474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05)
  • 10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-30)
  • 1 BLISTER PACK in 1 CARTON (63304-643-69) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (4)

63304-643-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05) 63304-643-17 10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11) 63304-643-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-30) 63304-643-69 1 BLISTER PACK in 1 CARTON (63304-643-69) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

risperidone (3 mg/1)

Linked Drug Pages (1)

Risperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8c155c45-e5c8-4358-90da-8f6d193ad88b", "openfda": {"nui": ["N0000175430"], "upc": ["0363304949308"], "unii": ["L6UH7ZF8HC"], "rxcui": ["401953", "401954", "403825", "616698", "616705"], "spl_set_id": ["f91f551e-926f-440d-83d2-357e9d7484fe"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05)", "package_ndc": "63304-643-05", "marketing_start_date": "20100806"}, {"sample": false, "description": "10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17)  / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)", "package_ndc": "63304-643-17", "marketing_start_date": "20100806"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-30)", "package_ndc": "63304-643-30", "marketing_start_date": "20100806"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63304-643-69)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "63304-643-69", "marketing_start_date": "20100806"}], "brand_name": "Risperidone", "product_id": "63304-643_8c155c45-e5c8-4358-90da-8f6d193ad88b", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63304-643", "generic_name": "Risperidone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA078474", "marketing_category": "ANDA", "marketing_start_date": "20100806", "listing_expiration_date": "20261231"}