NDC 0143-9502-01 Haloperidol
Haloperidol Lactate Injection Intramuscular

Package Information

What is NDC 0143-9502-01?

The NDC Code 0143-9502-01 is assigned to a package of 1 vial in 1 box / 10 ml in 1 vial of Haloperidol, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection and is administered via intramuscular form. The following table has all the important details about this NDC code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

Field Name	Field Value
NDC Code	0143-9502-01
Package Description	1 VIAL in 1 BOX / 10 mL in 1 VIAL
Product Code	0143-9502
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Haloperidol
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Haloperidol Lactate
Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.	Haloperidol is used to treat certain mental/mood disorders (e.g., schizophrenia, schizoaffective disorders). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also help prevent suicide in people who are likely to harm themselves. It also reduces aggression and the desire to hurt others. It can decrease negative thoughts and hallucinations. Haloperidol can also be used to treat uncontrolled movements and outbursts of words/sounds related to Tourette's syndrome. Haloperidol is also used for severe behavior problems in hyperactive children when other treatments or medications have not worked. Haloperidol is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).
11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.	00143950201
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk	RxCUI: 1719646 - haloperidol 5 MG in 1 ML Injection RxCUI: 1719646 - 1 ML haloperidol 5 MG/ML Injection RxCUI: 1719646 - haloperidol (as haloperidol lactate) 5 MG per 1 ML Injection RxCUI: 204416 - haloperidol 5 MG/ML Injectable Solution RxCUI: 204416 - haloperidol 5 MG/ML (as haloperidol lactate) Injectable Solution
Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.	Human Prescription Drug
Labeler Name	Hikma Pharmaceuticals Usa Inc.
Dosage Form	Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)	Intramuscular - Administration within a muscle.
Active Ingredient(s)	HALOPERIDOL LACTATE 5 mg/mL
Pharmacologic Class(es)	Typical Antipsychotic - [EPC] (Established Pharmacologic Class)
Sample Package Sample Package? This field Indicates whether this package is a sample packaging or not.	No
Marketing Category What is the Marketing Category? Product 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.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
FDA Application Number What is the FDA Application Number? This 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.	ANDA075858
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	06-19-2001
Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.	12-31-2023
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	0143 - Hikma Pharmaceuticals Usa Inc. 0143-9502 - Haloperidol 0143-9502-01 - 1 VIAL in 1 BOX / 10 mL in 1 VIAL

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0143-9502-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
00143950201	J1630	Haloperidol injection	5 MG	10	1	10	10

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