NDC 13107-061 Phentermine Hydrochloride
Tablet Oral

Product Information

Phentermine Hydrochloride is a human prescription drug product labeled by Aurolife Pharma, Llc. The product's dosage form is tablet and is administered via oral form.

Product Code13107-061
Proprietary Name 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.
Phentermine Hydrochloride
Non-Proprietary Name 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.
Phentermine Hydrochloride
Product Type 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.
Human Prescription Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Aurolife Pharma, Llc
Labeler Code13107
FDA Application Number 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.
ANDA203068
DEA Schedule 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.
Schedule IV (CIV) Substances
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-06-2014
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Phentermine Hydrochloride?


Product Characteristics

Color(s)WHITE (C48325 - OFF-WHITE WITH BLUE SPECKS)
ShapeCAPSULE (C48336)
Size(s)10 MM
Imprint(s)U40
Score2

Product Packages

NDC 13107-061-01

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $0.08002 per EA

NDC 13107-061-05

Package Description: 500 TABLET in 1 BOTTLE

NDC 13107-061-30

Package Description: 30 TABLET in 1 BOTTLE

NDC 13107-061-99

Package Description: 1000 TABLET in 1 BOTTLE

Price per Unit: $0.08002 per EA

Product Details

What are Phentermine Hydrochloride Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PHENTERMINE HYDROCHLORIDE 37.5 mg/1 - A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity.

Phentermine Hydrochloride Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 803353 - phentermine HCl 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet

Phentermine Hydrochloride Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

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]

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Phentermine Hydrochloride Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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/m2, or greater than or equal to 27 kg/m2 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/m2
Height (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/1.73m2). Avoid use of phentermine hydrochloride tablet in patients with eGFR less than 15 mL/min/1.73m2 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 X

Phentermine 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. [seeClinical 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/1.73m2), 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/1.73m2, 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 (Cmax) 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 Cmax and AUC increase 13% and 42%, respectively.

Specific Populations

Renal 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 [seeDosage 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 [seeIndications 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:

Package Label-Principal Display Panel – 37.5 Mg (100 Tablets Bottle)




NDC 13107-061-01
Phentermine Hydrochloride Tablets, USP CIV
37.5 mg
Rx only            100 Tablets
Aurobindo



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