NDC 75834-100 Benzphetamine 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:
75834-100
Proprietary Name:
Benzphetamine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Nivagen Pharmaceuticals, Inc.
Labeler Code:
75834
Start Marketing Date: [9]
01-15-2016
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - PEACH)
Shape:
ROUND (C48348)
Size(s):
10 MM
8 MM
Imprint(s):
511
051
Score:
2
1

Product Packages

NDC Code 75834-100-01

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 75834-100-05

Package Description: 500 TABLET in 1 BOTTLE

NDC Code 75834-100-30

Package Description: 30 TABLET in 1 BOTTLE

Product Details

What is NDC 75834-100?

The NDC code 75834-100 is assigned by the FDA to the product Benzphetamine Hydrochloride which is product labeled by Nivagen Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 75834-100-01 100 tablet in 1 bottle , 75834-100-05 500 tablet in 1 bottle , 75834-100-30 30 tablet 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 Benzphetamine Hydrochloride?

Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below.BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)Weight PoundsHeight (feet, inches)5'0"5'3"5'6"5'9"6'0"6'3"140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129240474339363330250494440373431Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.

Which are Benzphetamine Hydrochloride UNII Codes?

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

Which are Benzphetamine Hydrochloride 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 Benzphetamine 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:

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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".