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  4. NDC Product Code: 54868-1854 Hydroxyzine Pamoate

NDC 54868-1854 Hydroxyzine Pamoate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-1854?
  5. Hydroxyzine Pamoate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
54868-1854
Proprietary Name:
Hydroxyzine Pamoate
Product Type: [3]
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
ba04ac99-6321-4431-97e1-e18083d7b137
FDA Application Number: [6]
ANDA086183
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
05-14-1996
End Marketing Date: [10]
06-30-2012
Listing Expiration Date: [11]
06-30-2012
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - LIGHT GREEN/DARK GREEN)
GREEN (C48329 - WHITE)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
E613
E615
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-1854?

The NDC code 54868-1854 is assigned by the FDA to the product Hydroxyzine Pamoate which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 54868-1854-0 100 capsule in 1 bottle , 54868-1854-1 30 capsule in 1 bottle, plastic , 54868-1854-3 60 capsule in 1 bottle, plastic . 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 Hydroxyzine Pamoate?

Hydroxyzine is used to treat itching caused by allergies. It is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Hydroxyzine may also be used short-term to treat anxiety or to help you feel sleepy/relaxed before and after surgery.

Which are Hydroxyzine Pamoate UNII Codes?

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

Which are Hydroxyzine Pamoate Inactive Ingredients 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 Hydroxyzine Pamoate?

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:
  • RxCUI: 995253 - hydrOXYzine pamoate 25 MG Oral Capsule
  • RxCUI: 995253 - hydroxyzine pamoate 25 MG Oral Capsule
  • RxCUI: 995278 - hydrOXYzine pamoate 50 MG Oral Capsule
  • RxCUI: 995278 - hydroxyzine pamoate 50 MG Oral Capsule
  • RxCUI: 995278 - hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule

* Please review the disclaimer below.

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 ("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".