risperidone

Generic: risperidone

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-004
Product ID 27241-004_8ace73a4-053e-4bd8-ad32-b05807e2f6f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201003
Listing Expiration 2026-12-31
Marketing Start 2014-03-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241004
Hyphenated Format 27241-004

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
UPC
0327241006067 0327241003066 0327241002069 0327241004063 0327241005060 0327241001062
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 ANDA201003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (27241-004-06)
  • 500 TABLET in 1 BOTTLE (27241-004-50)
source: ndc

Packages (2)

Ingredients (1)

risperidone (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8ace73a4-053e-4bd8-ad32-b05807e2f6f5", "openfda": {"nui": ["N0000175430"], "upc": ["0327241006067", "0327241003066", "0327241002069", "0327241004063", "0327241005060", "0327241001062"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["095630bd-a77e-434e-94ee-f13da445d8f2"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (27241-004-06)", "package_ndc": "27241-004-06", "marketing_start_date": "20140328"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (27241-004-50)", "package_ndc": "27241-004-50", "marketing_start_date": "20140328"}], "brand_name": "RISPERIDONE", "product_id": "27241-004_8ace73a4-053e-4bd8-ad32-b05807e2f6f5", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "27241-004", "generic_name": "RISPERIDONE", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RISPERIDONE", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA201003", "marketing_category": "ANDA", "marketing_start_date": "20140328", "listing_expiration_date": "20261231"}