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  4. NDC Product Code: 52584-495 Promethazine Hydrochloride

NDC 52584-495 Promethazine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 52584-495?
  4. Promethazine Hydrochloride Uses
  5. Active Ingredients UNII Codes

Product Information

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

Get all the details for National Drug Code (NDC) 52584-495 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
52584-495
Proprietary Name:
Promethazine Hydrochloride
Product Type: [3]
Labeler Name: [5]
General Injectables & Vaccines, Inc
Labeler Code:
52584
Product Label ID:
36c9c162-90af-4f7b-9f56-5d81ed850dbe
FDA Application Number: [6]
ANDA083312
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
08-01-2010
End Marketing Date: [10]
06-30-2024
Listing Expiration Date: [11]
06-30-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 52584-495?

The NDC code 52584-495 is assigned by the FDA to the product Promethazine Hydrochloride which is product labeled by General Injectables & Vaccines, Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 52584-495-31 1 ampule in 1 bag / 1 ml in 1 ampule. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Promethazine Hydrochloride?

Promethazine hydrochloride injection is indicated for the following conditions:Amelioration of allergic reactions to blood or plasma.In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.Active treatment of motion sickness.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.As an adjunct to analgesics for the control of postoperative pain.Preoperative, postoperative, and obstetric (during labor) sedation.Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

Which are Promethazine Hydrochloride UNII Codes?

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

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] 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.

[11] 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] 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".