NDC 0378-0630

Iloperidone

Iloperidone

Iloperidone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Iloperidone.

Product ID0378-0630_9721328c-453d-4861-b352-22ee78a1a7f5
NDC0378-0630
Product TypeHuman Prescription Drug
Proprietary NameIloperidone
Generic NameIloperidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA207231
Labeler NameMylan Pharmaceuticals Inc.
Substance NameILOPERIDONE
Active Ingredient Strength1 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-0630-01

100 TABLET in 1 BOTTLE (0378-0630-01)
Marketing Start Date2017-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0630-01 [00378063001]

Iloperidone TABLET
Marketing CategoryANDA
Application NumberANDA207231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-20

NDC 0378-0630-91 [00378063091]

Iloperidone TABLET
Marketing CategoryANDA
Application NumberANDA207231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-20

NDC 0378-0630-88 [00378063088]

Iloperidone TABLET
Marketing CategoryANDA
Application NumberANDA207231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-20

Drug Details

Active Ingredients

IngredientStrength
ILOPERIDONE1 mg/1

OpenFDA Data

SPL SET ID:eeb0fcfd-e4e8-4fb1-9635-901dc9446235
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848732
  • 848736
  • 848740
  • 848744
  • 848748
  • 848728
  • 848722
    • UPC Code
  • 0303780630918
  • 0303780631915
  • 0303780633919
  • 0303780636910
  • 0303780632912
  • 0303780635913
  • 0303780634916

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Iloperidone" or generic name "Iloperidone"

    NDCBrand NameGeneric Name
    0378-0630IloperidoneIloperidone
    0378-0631IloperidoneIloperidone
    0378-0632IloperidoneIloperidone
    0378-0633IloperidoneIloperidone
    0378-0634IloperidoneIloperidone
    0378-0635IloperidoneIloperidone
    0378-0636IloperidoneIloperidone
    51672-4178IloperidoneIloperidone
    51672-4179IloperidoneIloperidone
    51672-4180IloperidoneIloperidone
    51672-4181IloperidoneIloperidone
    51672-4182IloperidoneIloperidone
    51672-4183IloperidoneIloperidone
    51672-4184IloperidoneIloperidone
    51672-4213IloperidoneIloperidone
    43068-101Fanaptiloperidone
    43068-102Fanaptiloperidone
    43068-104Fanaptiloperidone
    43068-106Fanaptiloperidone
    43068-108Fanaptiloperidone
    43068-110Fanaptiloperidone
    43068-112Fanaptiloperidone
    43068-113Fanaptiloperidone
    43068-901Fanaptiloperidone
    43068-902Fanaptiloperidone
    43068-903Fanaptiloperidone
    69189-0597FANAPTIloperidone
    69189-0665Fanaptiloperidone
    70518-1867Fanaptiloperidone
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