risperidone

Generic: risperidone

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 3 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-343
Product ID 43547-343_a5511d66-5602-4b66-88ad-66b4532fdfe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077493
Listing Expiration 2026-12-31
Marketing Start 2014-06-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547343
Hyphenated Format 43547-343

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UPC
0343547343064 0343547344061 0343547342067 0343547340063 0343547339067 0343547341060
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 ANDA077493 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (43547-343-06)
  • 500 TABLET in 1 BOTTLE (43547-343-50)
source: ndc

Packages (2)

43547-343-06 60 TABLET in 1 BOTTLE (43547-343-06) 43547-343-50 500 TABLET in 1 BOTTLE (43547-343-50)

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": "a5511d66-5602-4b66-88ad-66b4532fdfe1", "openfda": {"nui": ["N0000175430"], "upc": ["0343547343064", "0343547344061", "0343547342067", "0343547340063", "0343547339067", "0343547341060"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["43aa2a4f-1123-4f86-800b-9218882f7bcd"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (43547-343-06)", "package_ndc": "43547-343-06", "marketing_start_date": "20140601"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-343-50)", "package_ndc": "43547-343-50", "marketing_start_date": "20140601"}], "brand_name": "Risperidone", "product_id": "43547-343_a5511d66-5602-4b66-88ad-66b4532fdfe1", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43547-343", "generic_name": "Risperidone", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA077493", "marketing_category": "ANDA", "marketing_start_date": "20140601", "listing_expiration_date": "20261231"}