FDA Product

Phentermine HCL

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Phentermine HCL

FDA Product Code

80425-0118

Regulatory Information

NDC Product Code

80425-0118

Application Number

ANDA040555

Marketing Category

C73584

Effective Date

November 10, 2022

Territorial Authority

USA

FDA Title

Phentermine HCL 37.5mg Tablets

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC

DUNS Number

117023142

Active Ingredients

PHENTERMINE HYDROCHLORIDE

Quantity: 37.5 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIB

Active Moieties

PHENTERMINE

Code: C045TQL4WP

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