NDC 68083-137

Haloperidol Decanoate

Haloperidol Decanoate

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

Product ID68083-137_c10c795a-0eb8-4586-8444-0db27088fef2
NDC68083-137
Product TypeHuman Prescription Drug
Proprietary NameHaloperidol Decanoate
Generic NameHaloperidol Decanoate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2017-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA205241
Labeler NameGland Pharma Limited
Substance NameHALOPERIDOL DECANOATE
Active Ingredient Strength50 mg/mL
Pharm ClassesTypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68083-137-02

1 VIAL in 1 CARTON (68083-137-02) > 5 mL in 1 VIAL
Marketing Start Date2017-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-137-10 [68083013710]

Haloperidol Decanoate INJECTION
Marketing CategoryANDA
Application NumberANDA205241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-16

NDC 68083-137-02 [68083013702]

Haloperidol Decanoate INJECTION
Marketing CategoryANDA
Application NumberANDA205241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-16

NDC 68083-137-01 [68083013701]

Haloperidol Decanoate INJECTION
Marketing CategoryANDA
Application NumberANDA205241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-16

Drug Details

Active Ingredients

IngredientStrength
HALOPERIDOL DECANOATE50 mg/mL

OpenFDA Data

SPL SET ID:1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859867
  • 859871
  • 1719862
  • 1719803
  • 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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