risperidone

Generic: risperidone

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name risperidone
Generic Name risperidone
Labeler endo usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

risperidone 4 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-403
Product ID 49884-403_06d1f3a6-8673-4789-9a7f-3cc17cda4fed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077494
Listing Expiration 2026-12-31
Marketing Start 2009-06-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884403
Hyphenated Format 49884-403

Supplemental Identifiers

RxCUI
401953 401954 403825 616698 616705 645037
UPC
0349884315528 0349884311520 0349884402525 0349884315917 0349884403522 0349884401528 0349884403911
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 ANDA077494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 7 BLISTER PACK in 1 CARTON (49884-403-91) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-403-52)
source: ndc

Packages (1)

49884-403-91 7 BLISTER PACK in 1 CARTON (49884-403-91) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-403-52)

Ingredients (1)

risperidone (4 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": "06d1f3a6-8673-4789-9a7f-3cc17cda4fed", "openfda": {"nui": ["N0000175430"], "upc": ["0349884315528", "0349884311520", "0349884402525", "0349884315917", "0349884403522", "0349884401528", "0349884403911"], "unii": ["L6UH7ZF8HC"], "rxcui": ["401953", "401954", "403825", "616698", "616705", "645037"], "spl_set_id": ["d0ef6df3-67e5-47b1-bcf7-f67aa030caca"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 BLISTER PACK in 1 CARTON (49884-403-91)  / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-403-52)", "package_ndc": "49884-403-91", "marketing_start_date": "20090610"}], "brand_name": "Risperidone", "product_id": "49884-403_06d1f3a6-8673-4789-9a7f-3cc17cda4fed", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "49884-403", "generic_name": "Risperidone", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Risperidone", "active_ingredients": [{"name": "RISPERIDONE", "strength": "4 mg/1"}], "application_number": "ANDA077494", "marketing_category": "ANDA", "marketing_start_date": "20090610", "listing_expiration_date": "20261231"}