NDC Package 0527-1308-01 Phentermine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

0527-1308-01

Package Description:

100 CAPSULE in 1 BOTTLE

Product Code:

0527-1308

Proprietary Name:

Phentermine Hydrochloride

Usage Information:

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/m2Height (feet, inches)Weight(pounds)5'0"5'3"5'6"5'9"6'0"6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31The 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:

00527130801

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

Labeler Name:

Lannett Company, Inc.

Sample Package:

FDA Application Number:

ANDA087022

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

12-01-2007

End Marketing Date:

11-30-2021

Listing Expiration Date:

11-30-2021

Exclude Flag:

Code Structure:

0527 - Lannett Company, Inc.
- 0527-1308 - Phentermine Hydrochloride
  - 0527-1308-01 - 100 CAPSULE in 1 BOTTLE

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0527-1308-10	1000 CAPSULE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0527-1308-01?

The NDC Packaged Code 0527-1308-01 is assigned to a package of 100 capsule in 1 bottle of Phentermine Hydrochloride, labeled by Lannett Company, Inc.. The product's dosage form is and is administered via form.

Is NDC 0527-1308 included in the NDC Directory?

No, Phentermine Hydrochloride with product code 0527-1308 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Lannett Company, Inc. on December 01, 2007 and its listing in the NDC Directory is set to expire on November 30, 2021 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0527-1308-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 0527-1308-01?

The 11-digit format is 00527130801. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0527-1308-01	5-4-2	00527-1308-01

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