NDC 70518-2278 Phentermine Hydrochloride

Phentermine Hydrochloride

NDC Product Code 70518-2278

NDC Code: 70518-2278

Proprietary Name: Phentermine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phentermine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE WITH BLUE SPECKS)
Shape: CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
U40
Score: 2

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2278-0

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Phentermine Hydrochloride with NDC 70518-2278 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Phentermine Hydrochloride is phentermine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule IV (CIV) Substances What is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States.

Phentermine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENTERMINE HYDROCHLORIDE 37.5 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE (UNII: 68401960MK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Appetite Suppression - [PE] (Physiologic Effect)
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
  • Sympathomimetic Amine Anorectic - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA203068 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-23-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Phentermine

Phentermine is pronounced as (fen' ter meen)

Why is phentermine medication prescribed?
Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet. Phentermine is in a class of ...
[Read More]

* Please review the disclaimer below.

Phentermine Hydrochloride Product Label Images

Phentermine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 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


2, or greater than or equal to 27 kg/m


2 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.


BODY MASS INDEX (BMI), kg/m


2Height (feet, inches)


Weight


(pounds)


5'0"5'3"5'6"5'9"6'0"6'3"140


27


25


23


21


19


18


150


29


27


24


22


20


19


160


31


28


26


24


22


20


170


33


30


28


25


23


21


180


35


32


29


27


25


23


190


37


34


31


28


26


24


200


39


36


32


30


27


25


210


41


37


34


31


29


26


220


43


39


36


33


30


28


230


45


41


37


34


31


29


240


47


43


39


36


33


30


250


49


44


40


37


34


31


The limited usefulness of agents of this class, including phentermine, [see


Clinical Pharmacology (


12.1,


12.2)


] should be measured against possible risk factors inherent in their use such as those described below.

2.1 Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.


The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Phentermine is not recommended for use in pediatric patients less than or equal to 16 years of age.


Late evening medication should be avoided because of the possibility of resulting insomnia.


With dry hands, gently remove the phentermine hydrochloride tablet from the bottle. Immediately place the phentermine hydrochloride tablet on top of the tongue where it will dissolve, then swallow with or without water.

2.2 Dosage In Patients With Renal Impairment

The recommended maximum dosage of phentermine hydrochloride tablet is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m


2). Avoid use of phentermine hydrochloride tablet in patients with eGFR less than 15 mL/min/1.73m


2 or end-stage renal disease requiring dialysis [see


Use in Specific Populations (8.6) and


Clinical Pharmacology (12.3)]

3 Dosage Forms & Strengths

Phentermine hydrochloride tablets are white to off-white with blue specks, capsule shaped, uncoated tablets, debossed with “U40” on one side and break line on the other side, containing 37.5 mg phentermine hydrochloride USP (equivalent to 30 mg phentermine base).

4 Contraindications

  • History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors Hyperthyroidism Glaucoma Agitated states History of drug abuse Pregnancy [see
  • Use in Specific Populations (8.1)]
  • Nursing [see
  • Use in Specific Populations (8.3)]
  • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

5.1 Coadministration With Other Drug Products For Weight Loss

Phentermine hydrochloride tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of phentermine and these drug products is not recommended.

5.2 Primary Pulmonary Hypertension

Primary Pulmonary Hypertension (PPH) - a rare, frequently fatal disease of the lungs - has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.

5.3 Valvular Heart Disease

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

5.4 Development Of Tolerance, Discontinuation In Case Of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

5.5 Effect On The Ability To Engage In Potentially Hazardous Tasks

Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

5.6 Risk Of Abuse And Dependence

Phentermine is related chemically and pharmacologically to amphetamine (d- and d/l-amphetamine) and other related stimulant drugs that have been extensively abused. The possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See


Drug Abuse and Dependence (9)and


Overdosage (10) .The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

5.7 Usage With Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

5.8 Use In Patients With Hypertension

Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in blood pressure).

5.9 Use In Patients On Insulin Or Oral Hypoglycemic Medications For Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

6 Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections:


-   Primary pulmonary hypertension [see


Warnings and Precautions (5.2)]


-   Valvular heart disease [see


Warnings and Precautions (5.3)]


-   Effect on the ability to engage in potentially hazardous tasks [see


Warnings and Precautions (5.5)]


-   Withdrawal effects following prolonged high dosage administration [see


Drug Abuse and Dependence (9.3)]


The following adverse reactions to phentermine have been identified:


Cardiovascular


Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.


Central Nervous System


Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.


Gastrointestinal


Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.


Allergic


Urticaria.


Endocrine


Impotence, changes in libido.

7.1 Monoamine Oxidase Inhibitors

Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

7.2 Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

7.3 Insulin And Oral Hypoglycemic Medications

Requirements may be altered [see


Warnings and Precautions (5.9)].

7.4 Adrenergic Neuron Blocking Drugs

Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

8.1 Pregnancy

Pregnancy Category XPhentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [see


Clinical Pharmacology (12.1)]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

8.3 Nursing Mothers

It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

8.5 Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Renal Impairment

Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. [see


Clinical Pharmacology (12.3)].


Use caution when administering Phentermine to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m


2), limit the dosage of Phentermine to 15 mg daily [see


Dosage and Administration (2.2)]. Phentermine has not been studied in patients with eGFR less than 15 mL/min/1.73m


2, including end-stage renal disease requiring dialysis; avoid use in these populations.

9.1 Controlled Substance

Phentermine is a Schedule IV controlled substance.

9.2 Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

9.3 Dependence

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

10 Overdosage

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

10.1 Acute Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.


Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

10.2 Chronic Intoxication

Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See


Drug Abuse and Dependence (9.3).

11 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.

12.1 Mechanism Of Action

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d/l-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

12.2 Pharmacodynamics

Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

12.3 Pharmacokinetics

Following the administration of phentermine, phentermine reaches peak concentrations (C


max) after 3 to 4.4 hours.


Drug Interactions


 In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine C


max and AUC increase 13% and 42%, respectively.


Specific PopulationsRenal Impairment


Cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions was 62% to 85%. 


Systemic exposure of phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see


Dosage and Administration (2.2)and


Use in Specific Populations (8.6)].

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

14 Clinical Studies

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.


The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.


The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

16 How Supplied/Storage And Handling

Available as tablets containing 37.5 mg phentermine hydrochloride USP (equivalent to 30 mg phentermine base).


Phentermine hydrochloride tablets, USP are supplied as white to off-white with blue specks, capsule shaped, uncoated tablets, debossed with “U40” on one side and break line on the other side.


Bottles of 30       NDC 13107-061-30


Bottles of 100      NDC 13107-061-01


Bottles of 500      NDC 13107-061-05


Bottles of 1000     NDC 13107-061-99


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).


Keep out of the reach of children.

17 Patient Counseling Information

  • Patients must be informed that phentermine hydrochloride is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended [see
  • Indications and Usage (1) and
  • Warnings and Precautions (5)].
  • Patients must be instructed on how much phentermine to take, and when and how to take it [see
  • Dosage and Administration (2)].
  • Advise pregnant women and nursing mothers not to use phentermine [see
  • Use in Specific Populations (
  • 8.1,
  • 8.3)
  • ].
  • Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:
  • Development of primary pulmonary hypertension [see
  • Warnings and Precautions (5.2)]
  • Development of serious valvular heart disease [see
  • Warnings and Precautions (5.3) ]Effects on the ability to engage in potentially hazardous tasks [see
  • Warnings and Precautions (5.5)]
  • The risk of an increase in blood pressure [see
  • Warnings and Precautions (5.8)and
  • Adverse Reactions (6)]
  • The risk of interactions [see
  • Contraindications (4),
  • Warnings and Precautions (5) and
  • Drug Interactions (7)]
  • See also, for example,
  • Adverse Reactions (6)and
  • Use in Specific Populations (8).
  • The patients must also be informed aboutthe potential for developing tolerance and actions if they suspect development of tolerance [see
  • Warnings and Precautions (5.4)] and
  • The risk of dependence and the potential consequences of abuse [see
  • Warnings and Precautions (5.6),
  • Drug Abuse and Dependence (9), and
  • Overdosage (10)].
  • Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law.
  • Manufactured by:
  • Aurolife Pharma LLCDayton, NJ 08810
  • Manufactured for:
  • Aurobindo Pharma USA, Inc.Dayton, NJ 08810
  • Revised: 03/2017

* Please review the disclaimer below.