NDC 54868-6290 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:
54868-6290
Proprietary Name:
Phentermine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
07-29-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
WHITE (C48325 - LIGHT TURQUOISE BLUE OPAQUE/WHITE OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
LANNETT;1743
Score:
1

Product Packages

NDC Code 54868-6290-0

Package Description: 30 CAPSULE in 1 BOTTLE

Product Details

What is NDC 54868-6290?

The NDC code 54868-6290 is assigned by the FDA to the product Phentermine Hydrochloride which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-6290-0 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" 1402725232119 18 15029 27 24 22 2019 1603128262422 20 17033 30 28 25 2321 18035322927 2523 190373431 28 26 24 2003936323027 25 21041373431 29 26 2204339363330 28 230454137 343129 240 47 43 39 36 3330 250494440 373431The 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: 803348 - phentermine HCl 37.5 MG Oral Capsule
  • RxCUI: 803348 - phentermine hydrochloride 37.5 MG Oral Capsule
  • RxCUI: 803348 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 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".