NDC 68083-117

Haloperidol

Haloperidol

Haloperidol is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Haloperidol Lactate.

Product ID68083-117_9de3b250-7337-4c56-b9e6-93daf678e6ea
NDC68083-117
Product TypeHuman Prescription Drug
Proprietary NameHaloperidol
Generic NameHaloperidol
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2016-01-04
Marketing CategoryANDA / ANDA
Application NumberANDA076774
Labeler NameGland Pharma Limited
Substance NameHALOPERIDOL LACTATE
Active Ingredient Strength5 mg/mL
Pharm ClassesTypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-117-01

10 SYRINGE in 1 BOX (68083-117-01) > 1 mL in 1 SYRINGE
Marketing Start Date2016-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-117-01 [68083011701]

Haloperidol INJECTION
Marketing CategoryANDA
Application NumberANDA076774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-04

Drug Details

Active Ingredients

IngredientStrength
HALOPERIDOL LACTATE5 mg/mL

OpenFDA Data

SPL SET ID:cd45c03b-f077-461d-a0e2-bdb987863c2f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1876502
  • 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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