Phentermine Hydrochloride
NDC Package 12634-552-91
Package Information
Phentermine Hydrochloride is uSP 15 mg and 30 mg is 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/m 2, or≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Marketed by Apotheca Inc., this product is identified by NDC 12634-552 and is authorized under FDA application ANDA040886.
Identification & Billing
- RxCUI: 968766 - phentermine HCl 15 MG Oral Capsule
- RxCUI: 968766 - phentermine hydrochloride 15 MG Oral Capsule
- RxCUI: 968766 - phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 12634 - Apotheca Inc.
- 12634-552 - Phentermine Hydrochloride
- 12634-552-91 - 1 CAPSULE in 1 BLISTER PACK
- 12634-552 - Phentermine Hydrochloride
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 (12634-552). Click a package code to view its specific billing and regulatory data.
* 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 12634-552-91 identifies a specific commercial package of 1 capsule in 1 blister pack of Phentermine Hydrochloride, 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 August 07, 2012. The current certification is valid through December 31, 2020.
How is this Apotheca Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 12634055291. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
