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  4. NDC Product Code: 53217-334 Phentermine Hydrochloride

NDC 53217-334 Phentermine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53217-334?
  5. Phentermine Hydrochloride 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:
53217-334
Proprietary Name:
Phentermine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aidarex Pharmaceuticals Llc
Labeler Code:
53217
Product Label ID:
35d26955-2ad7-4f84-9b51-6a573933a396
Start Marketing Date: [9]
01-20-2012
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GRAY (C48324)
ORANGE (C48331)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
LANNETT;1742
Score:
1

Product Packages

NDC Code 53217-334-30

Package Description: 30 CAPSULE in 1 BOTTLE

Product Details

What is NDC 53217-334?

The NDC code 53217-334 is assigned by the FDA to the product Phentermine Hydrochloride which is product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53217-334-30 30 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 Phentermine Hydrochloride?

Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).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 x 0.0254 = meters.  BODY MASS INDEX (BMI), kg/m2 Height (feet, inches) Weight(pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3"  140  27  25  23  21  19  18  150  29  27  24  22  20  19  160  31  28  26  24  22  20  170  33  30  28  25  23  21  180  35  32  29  27  25  23  190  37  34  31  28  26  24  200  39  36  32  30  27  25  210  41  37  34  31  29  26  220  43  39  36  33  30  28  230  45  41  37  34  31  29  240  47  43  39  36  33  30  250  49  44  40  37  34  31The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

Which are Phentermine Hydrochloride UNII Codes?

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

Which are Phentermine 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 Phentermine 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:
  • RxCUI: 968766 - phentermine HCl 15 MG Oral Capsule
  • RxCUI: 968766 - phentermine hydrochloride 15 MG Oral Capsule
  • RxCUI: 968766 - phentermine hydrochloride 15 MG (equivalent to phentermine 12 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.

[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".