Phendimetrazine Tartrate
NDC Package 12634-910-45

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Phendimetrazine Tartrate is phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. Marketed by Apotheca Inc., this product is identified by NDC 12634-910 and is authorized under FDA application NDA018074.

Identification & Billing

NDC Package Code
12634-910-45
Package Description
45 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
11-Digit Billing Format
12634091045
RxNorm Crosswalk
  • RxCUI: 979543 - phendimetrazine tartrate 105 MG 24HR Extended Release Oral Capsule
  • RxCUI: 979543 - 24 HR phendimetrazine tartrate 105 MG Extended Release Oral Capsule
  • RxCUI: 979543 - phendimetrazine 105 MG 24 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Phendimetrazine Tartrate
Dosage Form
-
Usage Information
Phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.

Regulatory & Marketing

Labeler Name
Apotheca Inc.
FDA Application #
NDA018074
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-06-1977
Listing Expiration
12-31-2019
Exclude Flag
I
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 (12634-910). Click a package code to view its specific billing and regulatory data.

10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
35 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
40 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
42 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
50 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
12 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
28 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
6 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
9 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
24 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
28 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
21 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
12 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
3 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
5 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
6 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
8 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
9 CAPSULE, EXTENDED RELEASE 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 12634-910-45 identifies a specific commercial package of 45 capsule, extended release in 1 bottle of Phendimetrazine Tartrate, labeled by Apotheca Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Apotheca Inc. on September 06, 1977. The current certification is valid through December 31, 2019.

What are the primary indications for this medication?

Phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.

How is this Apotheca Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634091045. 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)
12634-910-45
11-Digit CMS (5-4-2)
12634-0910-45

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