NDC 0378-0334

Haloperidol

Haloperidol

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

Product ID0378-0334_4a4b89e9-3e02-421b-88c5-f124c025a75e
NDC0378-0334
Product TypeHuman Prescription Drug
Proprietary NameHaloperidol
Generic NameHaloperidol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA070278
Labeler NameMylan Pharmaceuticals Inc.
Substance NameHALOPERIDOL
Active Ingredient Strength10 mg/1
Pharm ClassesTypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-0334-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0334-01)
Marketing Start Date2009-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0334-10 [00378033410]

Haloperidol TABLET
Marketing CategoryANDA
Application NumberANDA070278
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-17
Marketing End Date2016-11-29

NDC 0378-0334-01 [00378033401]

Haloperidol TABLET
Marketing CategoryANDA
Application NumberANDA070278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-17

Drug Details

Active Ingredients

IngredientStrength
HALOPERIDOL10 mg/1

OpenFDA Data

SPL SET ID:c559b0b0-4087-d12a-e718-c18ccb6811e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310671
  • 197754
  • 310672
  • 310670
  • 314035
  • 314034
  • Pharmacological Class

    • Typical Antipsychotic [EPC]
    • Typical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    0093-9604HaloperidolHaloperidol lactate
    0121-0581HaloperidolHaloperidol
    0143-9319HaloperidolHaloperidol lactate
    0143-9501HaloperidolHaloperidol lactate
    0143-9502HaloperidolHaloperidol Lactate
    0378-0214Haloperidolhaloperidol
    0378-0257Haloperidolhaloperidol
    0378-0327Haloperidolhaloperidol
    0378-0334Haloperidolhaloperidol
    0378-0335Haloperidolhaloperidol
    0378-0351Haloperidolhaloperidol
    68083-117HaloperidolHaloperidol
    68084-250HaloperidolHaloperidol
    68084-249HaloperidolHaloperidol
    68258-7077HaloperidolHaloperidol
    68382-079HaloperidolHaloperidol
    68382-081HaloperidolHaloperidol
    68382-080HaloperidolHaloperidol
    70518-0035HaloperidolHaloperidol
    70518-0023HaloperidolHaloperidol
    70518-0728HaloperidolHaloperidol
    70518-0831HaloperidolHaloperidol
    70518-0776HaloperidolHaloperidol
    70518-1599HaloperidolHaloperidol
    70518-1182HaloperidolHaloperidol
    70518-1720HaloperidolHaloperidol
    70518-1803HaloperidolHaloperidol
    70518-1269HaloperidolHaloperidol
    70518-1529HaloperidolHaloperidol
    0615-2597HaloperidolHaloperidol
    0615-2596HaloperidolHaloperidol
    0615-2594HaloperidolHaloperidol
    0615-2598HaloperidolHaloperidol
    0615-2595HaloperidolHaloperidol
    0781-1396HaloperidolHaloperidol
    0781-1391HaloperidolHaloperidol
    0781-1392HaloperidolHaloperidol
    0781-1393HaloperidolHaloperidol
    0781-1398HaloperidolHaloperidol
    0781-1397HaloperidolHaloperidol
    0904-5925HaloperidolHaloperidol
    0904-5924HaloperidolHaloperidol
    0904-5923HaloperidolHaloperidol
    0904-6413HaloperidolHaloperidol
    10147-0911HaloperidolHaloperidol
    17856-0581HaloperidolHaloperidol
    17478-110HaloperidolHaloperidol
    21695-653HaloperidolHaloperidol
    25021-806haloperidolhaloperidol
    43063-551HaloperidolHaloperidol

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