NDC 53002-6212 Hydroxyzine Pamoate

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:
53002-6212
Proprietary Name:
Hydroxyzine Pamoate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Start Marketing Date: [9]
12-14-1981
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

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

Product Packages

NDC Code 53002-6212-1

Package Description: 10 CAPSULE in 1 BOTTLE

NDC Code 53002-6212-2

Package Description: 20 CAPSULE in 1 BOTTLE

NDC Code 53002-6212-3

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 53002-6212-5

Package Description: 15 CAPSULE in 1 BOTTLE

Product Details

What is NDC 53002-6212?

The NDC code 53002-6212 is assigned by the FDA to the product Hydroxyzine Pamoate which is product labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 53002-6212-1 10 capsule in 1 bottle , 53002-6212-2 20 capsule in 1 bottle , 53002-6212-3 30 capsule in 1 bottle , 53002-6212-5 15 capsule in 1 bottle . 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:

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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.
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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.

[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".