iloperidone

Generic: iloperidone

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name iloperidone
Generic Name iloperidone
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

iloperidone 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0635
Product ID 0378-0635_30392c6b-2f42-6e82-e063-6394a90a0c88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207231
Listing Expiration 2026-12-31
Marketing Start 2017-03-20

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780635
Hyphenated Format 0378-0635

Supplemental Identifiers

RxCUI
848722 848728 848732 848736 848740 848744 848748
UPC
0303780631915 0303780633919 0303780636910 0303780634916 0303780632912 0303780635913 0303780630918
UNII
VPO7KJ050N
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 iloperidone (source: ndc)
Generic Name iloperidone (source: ndc)
Application Number ANDA207231 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0378-0635-01)
  • 10 BLISTER PACK in 1 CARTON (0378-0635-88) / 10 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (0378-0635-91)
source: ndc

Packages (3)

0378-0635-01 100 TABLET in 1 BOTTLE (0378-0635-01) 0378-0635-88 10 BLISTER PACK in 1 CARTON (0378-0635-88) / 10 TABLET in 1 BLISTER PACK 0378-0635-91 60 TABLET in 1 BOTTLE (0378-0635-91)

Ingredients (1)

iloperidone (10 mg/1)

Linked Drug Pages (1)

ILOPERIDONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30392c6b-2f42-6e82-e063-6394a90a0c88", "openfda": {"nui": ["N0000175430"], "upc": ["0303780631915", "0303780633919", "0303780636910", "0303780634916", "0303780632912", "0303780635913", "0303780630918"], "unii": ["VPO7KJ050N"], "rxcui": ["848722", "848728", "848732", "848736", "848740", "848744", "848748"], "spl_set_id": ["eeb0fcfd-e4e8-4fb1-9635-901dc9446235"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0378-0635-01)", "package_ndc": "0378-0635-01", "marketing_start_date": "20170320"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0378-0635-88)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0378-0635-88", "marketing_start_date": "20170320"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0378-0635-91)", "package_ndc": "0378-0635-91", "marketing_start_date": "20170320"}], "brand_name": "ILOPERIDONE", "product_id": "0378-0635_30392c6b-2f42-6e82-e063-6394a90a0c88", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0378-0635", "generic_name": "iloperidone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ILOPERIDONE", "active_ingredients": [{"name": "ILOPERIDONE", "strength": "10 mg/1"}], "application_number": "ANDA207231", "marketing_category": "ANDA", "marketing_start_date": "20170320", "listing_expiration_date": "20261231"}