NDC 52959-481 Hydroxyzine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
52959-481
Proprietary Name:
Hydroxyzine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
H.j Harkins Company Inc.
Labeler Code:
52959
Start Marketing Date: [9]
01-03-2017
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
H;500

Product Packages

NDC Code 52959-481-06

Package Description: 6 TABLET in 1 CONTAINER

NDC Code 52959-481-10

Package Description: 10 TABLET in 1 CONTAINER

NDC Code 52959-481-12

Package Description: 12 TABLET in 1 CONTAINER

NDC Code 52959-481-15

Package Description: 15 TABLET in 1 CONTAINER

NDC Code 52959-481-20

Package Description: 20 TABLET in 1 CONTAINER

NDC Code 52959-481-25

Package Description: 25 TABLET in 1 CONTAINER

NDC Code 52959-481-30

Package Description: 30 TABLET in 1 CONTAINER

NDC Code 52959-481-60

Package Description: 60 TABLET in 1 CONTAINER

Product Details

What is NDC 52959-481?

The NDC code 52959-481 is assigned by the FDA to the product Hydroxyzine Hydrochloride which is product labeled by H.j Harkins Company Inc.. The product's dosage form is . The product is distributed in 8 packages with assigned NDC codes 52959-481-06 6 tablet in 1 container , 52959-481-10 10 tablet in 1 container , 52959-481-12 12 tablet in 1 container , 52959-481-15 15 tablet in 1 container , 52959-481-20 20 tablet in 1 container , 52959-481-25 25 tablet in 1 container , 52959-481-30 30 tablet in 1 container , 52959-481-60 60 tablet in 1 container . 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 Hydrochloride?

Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.Hydroxyzine is contraindicated in patients with a prolonged QT interval.Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Which are Hydroxyzine Hydrochloride UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Hydroxyzine Hydrochloride?

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:

* Please review the disclaimer below.

Patient Education

Hydroxyzine


Hydroxyzine is used in adults and children to relieve itching caused by allergic skin reactions. It is also used alone or with other medications in adults and children to relieve anxiety and tension. Hydroxyzine is also used along with other medications in adults and children as a sedative before and after general anesthesia for surgery. Hydroxyzine is in a class of medications called antihistamines. It works by blocking the action of histamine a substance in the body that causes allergic symptoms. It also works by decreasing activity in the brain.
[Learn More]


* 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.

[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.

[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".