NDC 70069-384

HALOPERIDOL DECANOATE

Haloperidol Decanoate

HALOPERIDOL DECANOATE is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Haloperidol Decanoate.

Product ID70069-384_29085961-acdf-417b-a578-0261a5e76727
NDC70069-384
Product TypeHuman Prescription Drug
Proprietary NameHALOPERIDOL DECANOATE
Generic NameHaloperidol Decanoate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA209101
Labeler NameSomerset Therapeutics, LLC
Substance NameHALOPERIDOL DECANOATE
Active Ingredient Strength100 mg/mL
Pharm ClassesTypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70069-384-01

1 VIAL, MULTI-DOSE in 1 CARTON (70069-384-01) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-384-01 [70069038401]

HALOPERIDOL DECANOATE INJECTION
Marketing CategoryANDA
Application NumberANDA209101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-04

NDC 70069-384-05 [70069038405]

HALOPERIDOL DECANOATE INJECTION
Marketing CategoryANDA
Application NumberANDA209101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-04

Drug Details

Active Ingredients

IngredientStrength
HALOPERIDOL DECANOATE100 mg/mL

OpenFDA Data

SPL SET ID:f2bff27f-929f-4f7d-b3eb-084ebc2a885f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719862
  • 1719803
  • UPC Code
  • 0370069031018
  • 0370069382011
  • 0370069384015
  • 0370069030011
  • 0370069383018
  • 0370069381014
  • Pharmacological Class

    • Typical Antipsychotic [EPC]

    NDC Crossover Matching brand name "HALOPERIDOL DECANOATE" or generic name "Haloperidol Decanoate"

    NDCBrand NameGeneric Name
    0143-9295Haloperidol DecanoateHaloperidol Decanoate
    0143-9296Haloperidol DecanoateHaloperidol Decanoate
    0703-7011Haloperidol DecanoateHaloperidol Decanoate
    0703-7013Haloperidol DecanoateHaloperidol Decanoate
    0703-7021Haloperidol DecanoateHaloperidol Decanoate
    0703-7023Haloperidol DecanoateHaloperidol Decanoate
    0703-7121Haloperidol DecanoateHaloperidol Decanoate
    0703-7123Haloperidol DecanoateHaloperidol Decanoate
    0703-7131Haloperidol DecanoateHaloperidol Decanoate
    0703-7133Haloperidol DecanoateHaloperidol Decanoate
    10147-0921Haloperidol DecanoateHaloperidol Decanoate
    10147-0922Haloperidol DecanoateHaloperidol Decanoate
    25021-831haloperidol decanoatehaloperidol decanoate
    25021-833haloperidol decanoatehaloperidol decanoate
    68083-137Haloperidol DecanoateHaloperidol Decanoate
    68083-138Haloperidol DecanoateHaloperidol Decanoate
    70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE
    70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE
    70518-1809Haloperidol DecanoateHaloperidol Decanoate
    25021-834haloperidol decanoatehaloperidol decanoate
    63323-469Haloperidol DecanoateHaloperidol Decanoate
    63323-471Haloperidol DecanoateHaloperidol Decanoate
    64725-0471Haloperidol DecanoateHaloperidol Decanoate
    67457-381Haloperidol DecanoateHaloperidol Decanoate
    67457-409Haloperidol DecanoateHaloperidol Decanoate
    67457-410Haloperidol DecanoateHaloperidol Decanoate
    70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE
    70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE
    70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE
    70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE

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