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  4. NDC Product Code: 0527-1366 Phentermine Resin ER

NDC 0527-1366 Phentermine Resin ER

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0527-1366?
  5. Phentermine Resin ER 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:
0527-1366
Proprietary Name:
Phentermine Resin ER
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lannett Company, Inc.
Labeler Code:
0527
Product Label ID:
7ca86c66-409b-4852-8631-c3ada6e60738
Start Marketing Date: [9]
07-28-2011
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GRAY (C48324)
YELLOW (C48330 - GRAY OPAQUE/MAIZE OPAQUE CAPSULES)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
LCI;1398
LCI;1366
Score:
1

Product Packages

NDC Code 0527-1366-01

Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 0527-1366?

The NDC code 0527-1366 is assigned by the FDA to the product Phentermine Resin ER which is product labeled by Lannett Company, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0527-1366-01 100 capsule, extended release in 1 bottle, plastic . 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 Resin ER?

Phentermine resin extended-release 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/m2Height (feet, inches) Weight(pounds)5’0”5’3”5’6”5’9”6’0”6’3”140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129240474339363330250494440373431The 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 Resin ER UNII Codes?

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

Which are Phentermine Resin ER 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 Resin ER?

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: 826586 - phentermine resin 15 MG Extended Release Oral Capsule
  • RxCUI: 826832 - phentermine resin 30 MG Extended Release 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".