1. Home
  2. Labeler Index
  3. Softech Pharma Pvt. Ltd
  4. NDC Product Code: 48769-060 Diphenhydramine Hcl

NDC 48769-060 Diphenhydramine Hcl

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 48769-060?
  5. Diphenhydramine Hcl 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 because the listing data was inactivated by the FDA.
NDC Product Code:
48769-060
Proprietary Name:
Diphenhydramine Hcl
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Softech Pharma Pvt. Ltd
Labeler Code:
48769
Product Label ID:
3e45d7ea-2a97-422a-b73a-c48bc2d1dea5
Start Marketing Date: [9]
01-01-2013
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327)
Shape:
CAPSULE (C48336)
Size(s):
7 MM
Imprint(s):
R60
Score:
1

Product Packages

NDC Code 48769-060-99

Package Description: 5000 CAPSULE, LIQUID FILLED in 1 BAG

Product Details

What is NDC 48769-060?

The NDC code 48769-060 is assigned by the FDA to the product Diphenhydramine Hcl which is product labeled by Softech Pharma Pvt. Ltd. The product's dosage form is . The product is distributed in a single package with assigned NDC code 48769-060-99 5000 capsule, liquid filled in 1 bag . 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 Diphenhydramine Hcl?

Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing. It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects. It should not be used for common cold symptoms in children less than 6 years of age due to the risk of serious side effects, such as slow/shallow breathing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6.

Which are Diphenhydramine Hcl UNII Codes?

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

  • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
  • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

Which are Diphenhydramine Hcl 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 Diphenhydramine Hcl?

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.

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".