NDC 50458-254

Haldol Decanoate

Haloperidol Decanoate

Haldol Decanoate is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Haloperidol Decanoate.

Product ID50458-254_3f73424e-67ec-11e9-b071-92e20099106d
NDC50458-254
Product TypeHuman Prescription Drug
Proprietary NameHaldol Decanoate
Generic NameHaloperidol Decanoate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1986-01-14
Marketing CategoryNDA / NDA
Application NumberNDA018701
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameHALOPERIDOL DECANOATE
Active Ingredient Strength100 mg/mL
Pharm ClassesTypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50458-254-14

5 AMPULE in 1 BOX (50458-254-14) > 1 mL in 1 AMPULE
Marketing Start Date1986-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-254-14 [50458025414]

Haldol Decanoate INJECTION
Marketing CategoryNDA
Application NumberNDA018701
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1986-01-14

Drug Details

Active Ingredients

IngredientStrength
HALOPERIDOL DECANOATE100 mg/mL

OpenFDA Data

SPL SET ID:af0159a8-dff5-449a-aa2b-a0c430081e21
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1720026
  • 1719847
  • 1719803
  • 1719862
  • UPC Code
  • 0350458253030
  • 0350458254143
  • Pharmacological Class

    • Typical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    50458-254Haldol DecanoateHaldol Decanoate
    50458-253Haldol DecanoateHaldol Decanoate
    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

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