NDC Package 0527-1398-01 Phentermine Resin ER

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0527-1398-01
Package Description:
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Phentermine Resin ER
Usage Information:
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.
11-Digit NDC Billing Format:
00527139801
NDC to RxNorm Crosswalk:
  • RxCUI: 826586 - phentermine resin 15 MG Extended Release Oral Capsule
  • RxCUI: 826832 - phentermine resin 30 MG Extended Release Oral Capsule
  • Labeler Name:
    Lannett Company, Inc.
    Sample Package:
    No
    Start Marketing Date:
    07-28-2011
    Listing Expiration Date:
    12-31-2018
    Exclude Flag:
    I
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0527-1398-01?

    The NDC Packaged Code 0527-1398-01 is assigned to a package of 100 capsule, extended release in 1 bottle, plastic of Phentermine Resin ER, labeled by Lannett Company, Inc.. The product's dosage form is and is administered via form.

    Is NDC 0527-1398 included in the NDC Directory?

    No, Phentermine Resin ER with product code 0527-1398 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Lannett Company, Inc. on July 28, 2011 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0527-1398-01?

    The 11-digit format is 00527139801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20527-1398-015-4-200527-1398-01