Chlorpromazine Hydrochloride
NDC 0904-7129

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0904-7129?
  5. Chlorpromazine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Chlorpromazine Hydrochloride is a ANDA-approved product labeled by Major Pharmaceuticals. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a brown product. This product entry covers the primary NDC 0904-7129 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0904-7129
Proprietary Name:
Chlorpromazine Hydrochloride
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Major Pharmaceuticals
Labeler Code:
0904
Product Label ID:
d58570a0-58b0-4662-b2ad-aa8d1463b4c1
FDA Application Number: [6]
ANDA213368
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-27-2020
End Marketing Date: [10]
12-31-2025
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
D

Product Characteristics

Color(s):
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
11;29
Score:
1

Code Structure Chart

Product Details

What is NDC 0904-7129?

The NDC code 0904-7129 is assigned by the FDA to the product Chlorpromazine Hydrochloride. This pharmaceutical product is labeled by Major Pharmaceuticals and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0904-7129-61. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

For the management of manifestations of psychotic disorders.For the treatment of schizophrenia.To control nausea and vomiting.For relief of restlessness and apprehension before surgery.For acute intermittent porphyria.As an adjunct in the treatment of tetanus.To control the manifestations of the manic type of manic-depressive illness.For relief of intractable hiccups.For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Chlorpromazine


Chlorpromazine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) and other psychotic disorders (conditions that cause difficulty telling the difference between things or ideas that are real and things or ideas that are not real) and to treat the symptoms of mania (frenzied, abnormally excited mood) in people who have bipolar disorder (manic depressive disorder; a condition that causes episodes of mania, episodes of depression, and other abnormal moods). Chlorpromazine is also used to treat severe behavior problems such as explosive, aggressive behavior and hyperactivity in children 1 to 12 years of age. Chlorpromazine is also used to control nausea and vomiting, to relieve hiccups that have lasted one month or longer, and to relieve restlessness and nervousness that may occur just before surgery. Chlorpromazine is also used to treat acute intermittent porphyria (condition in which certain natural substances build up in the body and cause stomach pain, changes in thinking and behavior, and other symptoms). Chlorpromazine is also used along with other medications to treat tetanus (a serious infection that may cause tightening of the muscles, especially the jaw muscle). Chlorpromazine is in a class of medications called conventional antipsychotics. It works by changing the activity of certain natural substances in the brain and other parts of the body.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".