NDC 52605-022 Phentermine 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:
52605-022
Proprietary Name:
Phentermine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Polygen Pharmaceuticals Inc.
Labeler Code:
52605
Start Marketing Date: [9]
11-18-2016
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
P22
Score:
2

Product Packages

NDC Code 52605-022-01

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 52605-022-10

Package Description: 1000 TABLET in 1 BOTTLE

Product Details

What is NDC 52605-022?

The NDC code 52605-022 is assigned by the FDA to the product Phentermine Hydrochloride which is product labeled by Polygen Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 52605-022-01 100 tablet in 1 bottle , 52605-022-10 1000 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 Phentermine Hydrochloride?

Phentermine hydrochloride tablets, USP  is 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.The limited usefulness of agents of this class, including  Phentermine hydrochloride tablets, USP [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: 803353 - phentermine HCl 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet

* 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".