risperidone

Generic: risperidone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone .5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-909
Product ID 42291-909_48ec0cc0-9916-db6b-e063-6294a90a4bea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078071
Listing Expiration 2027-12-31
Marketing Start 2021-09-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291909
Hyphenated Format 42291-909

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UPC
0342291913509 0342291911505 0342291912502 0342291908505 0342291909502 0342291910508
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 ANDA078071 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (42291-909-50)
source: ndc

Packages (1)

42291-909-50 500 TABLET in 1 BOTTLE (42291-909-50)

Ingredients (1)

risperidone (.5 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": "48ec0cc0-9916-db6b-e063-6294a90a4bea", "openfda": {"nui": ["N0000175430"], "upc": ["0342291913509", "0342291911505", "0342291912502", "0342291908505", "0342291909502", "0342291910508"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["cba7628c-30b2-5d26-e053-2a95a90a3e57"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42291-909-50)", "package_ndc": "42291-909-50", "marketing_start_date": "20210910"}], "brand_name": "Risperidone", "product_id": "42291-909_48ec0cc0-9916-db6b-e063-6294a90a4bea", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "42291-909", "generic_name": "Risperidone", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": ".5 mg/1"}], "application_number": "ANDA078071", "marketing_category": "ANDA", "marketing_start_date": "20210910", "listing_expiration_date": "20271231"}