FANAPT

Product NDC
43068-905
11-digit product format
430680905
Labeler code
43068
Product ID
43068-905_2609a5b3-d7ec-48a9-a32b-54a9b207f9aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ILOPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Vanda Pharmaceuticals Inc.
Application
NDA022192
Marketing category
NDA
Marketing start
2024-06-11
Substance
ILOPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VPO7KJ050NILOPERIDONE133454-47-4ILOPERIDONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43068-905-144306809051414 TABLET in 1 BOTTLE (43068-905-14) 14 tablet2024-06-11YesNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FANAPTVanda Pharmaceuticals Inc.2026-05-06HUMAN PRESCRIPTION DRUG LABEL35