PHENTERMINE HYDROCHLORIDE tablet

Phentermine Hydrochloride by

Drug Labeling and Warnings

Phentermine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., H.J. Harkins Comapny., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Description

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.

Package and Display

INGREDIENTS AND APPEARANCE

PHENTERMINE HYDROCHLORIDE 
phentermine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52959-812
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)	PHENTERMINE HYDROCHLORIDE	37.5 mg

Product Characteristics
Color	white (Off-white with blue specks)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	MP;273
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-812-21	21 in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2017
2	NDC: 52959-812-45	45 in 1 CONTAINER; Type 0: Not a Combination Product	07/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203068	07/18/2017

Labeler - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Business Operations
H.J. Harkins Comapny., Inc.		147681894	repack(52959-812) , relabel(52959-812) , manufacture(52959-812)