Phentermine hydrochloride, USP 37.5 mg is indicated as 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, ...
Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet (37.5 mg) or one capsule (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desir...
Phentermine hydrochloride tablets, USP 37.5 mg (equivalent to 30 mg phentermine base), are supplied as blue and white mottled oval tablets debossed “K” left to bisect “25” on one side and plain on the other side. NDC: 63629-4385-1: 7 Tablets in a BOTTLE NDC: 63629-4385-2: 30 Tablets in a BOTTLE NDC: 63629-4385-3: 14 Tablets in a BOTTLE NDC: 63629-4385-4: 60 Tablets in a BOTTLE NDC: 63629-4385-5: 28 Tablets in a BO...
www.fda.gov/medwatchPhentermine hydrochloride, USP 37.5 mg is indicated as 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.
The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet (37.5 mg) or one capsule (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half-tablets (18.75 mg) two times a day.
Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.
Late Evening medication should be avoided because of the possibility of resulting insomnia.
The recommended maximum dosage of phentermine hydrochloride is 15 mg daily for patients with severe renal impairments (eGFR 15 to 29 mL/min/1.73 m 2). Avoid use of phentermine hydrochloride in patients with eGFR less than 15 mL/min/1.73 m 2 or end-stage renal disease requiring dialysis [see Use in Specific Populations ( 8.6) and Clinical Pharmacology ( 12.3) ].
Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).
Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).
Phentermine is 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.
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.
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.
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.
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.
Phentermine is related chemically and pharmacologically to amphetamine (d- and d/l-amphetamine) and to other related stimulant drugs 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.
Concomitant use of alcohol with phentermine may result in an adverse drug reaction.
Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in blood pressure).
A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.
The following adverse reactions are described, or described in greater detail, in other section:
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.
Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.
Concomitant use of alcohol with phentermine may result in an adverse drug reaction.
Requirements may be altered [ see Warnings and Precautions ( 5.9 )].
Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.
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.
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.
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.
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.
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 hydrochloride to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2), limit the dosage of phentermine hydrochloride to 15 mg daily [see Dosage and Administration ( 2.2)]. Phentermine hydrochloride has not been studied in patients with eGFR less than 15 mL/min/1.73 m 2, including end-stage renal disease requiring dialysis; avoid use in these populations.
Phentermine is a Schedule IV controlled substance.
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.
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 that 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.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of 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.
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) .
Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:
Phentermine hydrochloride 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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).
Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&C Red #33, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide.
Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.
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.
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.
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 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 [see Dosage and Administration ( 2.2) and Use in Specific Populations ( 8.6)].
Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.
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.
Phentermine hydrochloride tablets, USP 37.5 mg (equivalent to 30 mg phentermine base), are supplied as blue and white mottled oval tablets debossed “K” left to bisect “25” on one side and plain on the other side.
NDC: 63629-4385-1: 7 Tablets in a BOTTLE
NDC: 63629-4385-2: 30 Tablets in a BOTTLE
NDC: 63629-4385-3: 14 Tablets in a BOTTLE
NDC: 63629-4385-4: 60 Tablets in a BOTTLE
NDC: 63629-4385-5: 28 Tablets in a BOTTLE
NDC: 63629-4385-6: 24 Tablets in a BOTTLE
NDC: 63629-4385-7: 45 Tablets in a BOTTLE
NDC: 63629-4385-8: 90 Tablets in a BOTTLE
NDC: 63629-4385-9: 21 Tablets in a BOTTLE
Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Dispense in a tight, light resistant container as defined in the USP/NF, with a child-resistant closure (as required).
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
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) ].
Advice 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:
See also, for example, Adverse Reactions ( 6) and Use in Specific Populations ( 8) .
The patients must also be informed about
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.
Regitine ® is a registered trademark of CIBA PHARMACEUTICAL PRODUCTS, INC.
Manufactured by:
KVK-TECH INC.
110 Terry Drive
Newtown, PA 18940
Item ID # 6071/07 05/2021
Manufacturer’s Code: 10702
Phentermine Hcl 37.5mg(CIV) Tab.
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENTERMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
| 32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab | Product name | 2 | 20230717 |
| ebeae3eb-385d-62da-8827-5ffa80b14e90 | Product name | 2 | 20170810 |
| 1d682039-1122-1cb7-f3f4-c0a028b98748 | Product name | 4 | 20170124 |
| 8ef9ca65-1a6c-7225-351d-36066d0f8e56 | Product name | 3 | 20161229 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-4385-1 | Phentermine Hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | 1009 | |
| 63629-4385-2 | Phentermine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1009 | |
| 63629-4385-3 | Phentermine Hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | 1009 | |
| 63629-4385-4 | Phentermine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1009 | |
| 63629-4385-5 | Phentermine Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | 1009 | |
| 63629-4385-6 | Phentermine Hydrochloride | 24 in 1 BOTTLE | TABLET | 24 | 1009 | |
| 63629-4385-7 | Phentermine Hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | 1009 | |
| 63629-4385-8 | Phentermine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 1009 | |
| 63629-4385-9 | Phentermine Hydrochloride | 21 in 1 BOTTLE | TABLET | 21 | 1009 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-4385 | PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1009 | Current NDC, Legacy NDC, 9 package rows | 20240821_2bd5487d-10da-4ae0-9105-273e1a5efdcb.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-4385-1 | EA - Each | 63629-4385 | 8c76eecf-1284-4e3f-a24c-51ff821c186a | 1 | 2025-08-11 |
| 63629-4385-2 | EA - Each | 63629-4385 | 03556005-a619-47cd-aa43-179bf6403380 | 1 | 2025-08-11 |
| 63629-4385-3 | EA - Each | 63629-4385 | 5654fc89-deff-4698-a72b-2912b30a7f35 | 1 | 2025-08-11 |
| 63629-4385-6 | EA - Each | 63629-4385 | f9dbcb05-57ce-4af2-b6e7-5cb0c42d8f03 | 1 | 2025-08-11 |
| 63629-4385-8 | EA - Each | 63629-4385 | 4d897521-1ef2-4194-8518-f5e6bde0259f | 1 | 2025-08-11 |
| 10702-025-01 | EA - Each | 10702-025 | 4f4b30e4-313a-447e-81ff-b7538a300ab0 | 1 | 2013-02-13 |
| 10702-025-03 | EA - Each | 10702-025 | c5a1d001-cc2d-4ea6-83e3-58e7c048661c | 1 | 2013-02-13 |
| 10702-025-10 | EA - Each | 10702-025 | 123b8669-c33f-4149-aa8f-1ad141bb746f | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0K2I505OTV | 1000 | |
| PHENTERMINE | ACTIVE MOIETY | C045TQL4WP | 1000 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1000 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1000 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1000 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1000 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1000 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1000 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63629-4385 | 63629-4385-1, 63629-4385-2, 63629-4385-3, 63629-4385-4, 63629-4385-5, 63629-4385-6, 63629-4385-7, 63629-4385-8, 63629-4385-9 |
| 10702-025 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCROSE | C151H8M554 | IACT |
| PHENTERMINE HYDROCHLORIDE | 0K2I505OTV | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040876-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 |
| Application-product | TE code |
|---|---|
| A040876-001 | AA |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040876-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040876-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040876-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040876-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040876-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040876-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040876-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040876-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040876-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040876-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040876-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040876-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040876-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040876-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040876-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040876-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040876-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040876-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040876-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040876-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040876-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040876-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040876-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040876-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040876-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040876-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040876-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040876-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040876-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040876-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040876-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040876-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040876-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040876-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040876-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040876-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040876-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040876-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040876-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040876-001 | AA | 1 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd5487d-10da-4ae0-9105-273e1a5efdcb | 2024-08-20 | Warnings, Adverse reactions | 63629-4385-2 63629-4385-1 63629-4385-4 63629-4385-9 63629-4385-7 63629-4385-8 63629-4385-5 63629-4385-3 63629-4385-6 63629-4385 63629438507 63629438501 63629438502 63629438505 63629438504 63629438509 63629438503 63629438508 63629438506 07e8afaf-c273-4f13-81fe-1065ec101e71 2bd5487d-10da-4ae0-9105-273e1a5efdcb |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | KVK-TECH, Inc. | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 2024-02-14 | Warnings, Adverse reactions | 10702-025 |
Adverse event summaries are temporarily unavailable. Other product information remains available.