Phentermine Hydrochloride Capsule
NDC Package 84053-910-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Phentermine Hydrochloride capsules is phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m2, or greater than or equal to 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. This formulation utilizes a capsule delivery system. Marketed by Martek Pharmacal Co., this product is identified by NDC 84053-910 and is authorized under FDA application ANDA202248.

Identification & Billing

NDC Package Code
84053-910-07
Package Description
7 CAPSULE in 1 BOTTLE
Product Code
84053-910
11-Digit Billing Format
84053091007
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Phentermine Hydrochloride
Non-Proprietary Name
Phentermine Hydrochloride
Substance Name
Phentermine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENTERMINE HYDROCHLORIDE 30 mg/1
Pharmacologic Class
Usage Information
Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m2, or greater than or equal to 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.The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Martek Pharmacal Co.
Product Type
Human Prescription Drug
FDA Application #
ANDA202248
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2024
End Marketing Date
04-29-2028
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (84053-910). Click a package code to view its specific billing and regulatory data.

84053-910-14
14 CAPSULE in 1 BOTTLE
84053-910-21
21 CAPSULE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84053-910-07 identifies a specific commercial package of 7 capsule in 1 bottle of Phentermine Hydrochloride, a human prescription drug labeled by Martek Pharmacal Co.. This capsule is formulated for oral use and contains phentermine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Martek Pharmacal Co. on February 12, 2024.

How is this Martek Pharmacal Co. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84053091007. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
84053-910-07
11-Digit CMS (5-4-2)
84053-0910-07

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.