PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet 
H.J. Harkins Company, Inc.


Indications & Usage

Phentermine hydrochloride tablets USP 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 greater than or equal to

30 kg/m , or greater than or equal to 27 kg/m 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.

Phentermine Indications and usage


Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Its chemical name is a,a- dimethylphenethylamine hydrochloride. The structural formula is as follows:

Phentermine hydrochloride USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Phentermine hydrochloride tablets USP are available as an oral tablet containing 37.5 mg of phentermine hydrochloride USP (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet USP also contains the inactive ingredients microcrystalline cellulose, pregelatinized starch, anhydrous lactose, crospovidone, colloidal silicon dioxide, magnesium stearate, sucrose, corn starch and FD&C Blue #1. Phentermine

Package and Display


phentermine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52959-812
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Product Characteristics
Colorwhite (Off-white with blue specks) Scoreno score
FlavorImprint Code MP;273
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-812-2121 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2017
2NDC:52959-812-4545 in 1 CONTAINER; Type 0: Not a Combination Product07/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - H.J. Harkins Company, Inc. (147681894)
NameAddressID/FEIBusiness Operations
H.J. Harkins Comapny., Inc.147681894repack(52959-812) , relabel(52959-812) , manufacture(52959-812)

Revised: 1/2018
Document Id: 61e4300d-6f7e-6951-e053-2a91aa0a974a
Set id: 5486d426-4704-0bed-e054-00144ff8d46c
Version: 2
Effective Time: 20180103
H.J. Harkins Company, Inc.