NDC 16590-185 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:
16590-185
Proprietary Name:
Phentermine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Start Marketing Date: [9]
12-01-2007
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - NATURAL/BLUE)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
LANNETT;1308
Score:
1

Product Packages

NDC Code 16590-185-20

Package Description: 20 CAPSULE in 1 BOTTLE

NDC Code 16590-185-30

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 16590-185-40

Package Description: 40 CAPSULE in 1 BOTTLE

Product Details

What is NDC 16590-185?

The NDC code 16590-185 is assigned by the FDA to the product Phentermine Hydrochloride which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 16590-185-20 20 capsule in 1 bottle , 16590-185-30 30 capsule in 1 bottle , 16590-185-40 40 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 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., 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 × 0.0254 = meters.The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) 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: 900038 - phentermine HCl 30 MG Oral Capsule
  • RxCUI: 900038 - phentermine hydrochloride 30 MG Oral Capsule
  • RxCUI: 900038 - phentermine hydrochloride 30 MG (equivalent to phentermine 24 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".