risperidone

Generic: risperidone

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risperidone 2 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-038
Product ID 13668-038_cd8bfb14-7054-4c69-b27f-8a960b5ecb5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079088
Listing Expiration 2027-12-31
Marketing Start 2009-01-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668038
Hyphenated Format 13668-038

Supplemental Identifiers

RxCUI
312828 312829 312830 312831 312832 314211
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 ANDA079088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13668-038-01)
  • 500 TABLET in 1 BOTTLE (13668-038-05)
  • 4200 TABLET in 1 BOTTLE (13668-038-55)
  • 60 TABLET in 1 BOTTLE (13668-038-60)
source: ndc

Packages (4)

13668-038-01 100 TABLET in 1 BOTTLE (13668-038-01) 13668-038-05 500 TABLET in 1 BOTTLE (13668-038-05) 13668-038-55 4200 TABLET in 1 BOTTLE (13668-038-55) 13668-038-60 60 TABLET in 1 BOTTLE (13668-038-60)

Ingredients (1)

risperidone (2 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": "cd8bfb14-7054-4c69-b27f-8a960b5ecb5f", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["312828", "312829", "312830", "312831", "312832", "314211"], "spl_set_id": ["a6347895-5f16-43b4-92a0-b9904ac81937"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13668-038-01)", "package_ndc": "13668-038-01", "marketing_start_date": "20090101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-038-05)", "package_ndc": "13668-038-05", "marketing_start_date": "20090101"}, {"sample": false, "description": "4200 TABLET in 1 BOTTLE (13668-038-55)", "package_ndc": "13668-038-55", "marketing_start_date": "20090101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (13668-038-60)", "package_ndc": "13668-038-60", "marketing_start_date": "20090101"}], "brand_name": "Risperidone", "product_id": "13668-038_cd8bfb14-7054-4c69-b27f-8a960b5ecb5f", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "13668-038", "generic_name": "Risperidone", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "2 mg/1"}], "application_number": "ANDA079088", "marketing_category": "ANDA", "marketing_start_date": "20090101", "listing_expiration_date": "20271231"}