55154-3566 NDC - HALOPERIDOL

Drug Information

  • Product NDC: 55154-3566
  • Proprietary Name: Haloperidol
  • Non Proprietary Name: Haloperidol
  • Active Ingredient(s): 5 mg/1 HALOPERIDOL
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Typical Antipsychotic [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Cardinal Health 107, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077580
Marketing Category: ANDA
Start Marketing Date:1/3/2008

Package Information

No. Package Code Package Description Billing Unit
155154-3566-010 BLISTER PACK in 1 BAG (55154-3566-0) / 1 TABLET in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC55154-3566This is the date that the labeler indicates was the start of its marketing of the drug product.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
PROPRIETARY NAMEHaloperidolName of Company corresponding to the labeler code segment of the Product NDC.
NON PROPRIETARY NAMEHaloperidolAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
DOSAGE FORM NAMETABLET 
ROUTE NAMEORAL 
START MARKETING DATE1/3/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA077580This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECardinal Health 107, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHALOPERIDOLAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESTypical Antipsychotic [EPC] 

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This page was last updated on: 12/6/2025

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