Diethylpropion Hydrochloride ER 75 mg Tablet, Extended Release, 21-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Sympathomimetic Amine Anorectic class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's a prescription medication used short-term to help adults with obesity lose weight, alongside a calorie-controlled diet. It's only for people with a BMI of 30 or higher who hav...
- What exactly is diethylpropion used for?
- It depends on which form you have. If you have the regular (immediate-release) tablet, you'd typically take it three times a day, about an hour before meals, and possibly in the mi...
- How do I take it — and does it matter when during the day?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII F68VH75CJC
A synthetic polymer made from acrylic acid that thickens and stabilizes liquid or gel formulations. It's used as a gelling agent and emulsifier to create the desired texture and consistency in topical medicines.
-
UNII 6N003M473W
Hypromellose acetate succinate is a modified cellulose polymer that dissolves in the small intestine. It's used as a coating material to protect the medicine from stomach acid and control where and when the drug is released in the digestive tract.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
-
UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diethylpropion Hydrochloride ER 75 mg 00527-1477-01 | Lannett | 100 tablets | $1.839 | — | Availability likely | — |
| Diethylpropion Hydrochloride ER 75 mg 62135-0489-30 | Chartwell | 30 tablets | $1.839 | — | Availability likely | — |
| Diethylpropion Hydrochloride ER 75 mg 81665-0109-10 | OMNIVIUM | 100 tablets | $1.839 | — | Availability likely | — |
| Diethylpropion Hydrochloride ER 75 mg 17224-0760-07 | Calvin | 7 tablets | — | — | FDA listed | — |
| Diethylpropion Hydrochloride ER 75 mg 43063-0532-07 | PD-Rx | 7 tablets | — | — | FDA listed | — |
| Diethylpropion Hydrochloride ER 75 mg 50090-0120-00 | A-S | 30 tablets | — | — | FDA listed | — |
| Diethylpropion Hydrochloride ER 75 mg 63187-0621-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Diethylpropion Hydrochloride ER 75 mg 68071-3837-01 | NuCare | 100 tablets | — | — | FDA listed | — |
| Diethylpropion Hydrochloride ER 75 mgthis 71335-0049-07 | Bryant | 21 tablets | — | — | FDA listed | — |
| Diethylpropion Hydrochloride Er 75 mg 72189-0307-30 | Directrx | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-0049-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-1) | 2012-04-12 | Active |
| 71335-0049-02 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-2) | 2012-04-12 | Active |
| 71335-0049-03 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-3) | 2012-04-12 | Active |
| 71335-0049-04 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-4) | 2012-04-12 | Active |
| 71335-0049-05 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-5) | 2012-04-12 | Active |
| 71335-0049-06 | 84 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-6) | 2012-04-12 | Active |
| 71335-0049-07 You're viewing this | 21 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-7) | 2012-04-12 | Active |
| 71335-0049-08 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-8) | 2012-04-12 | Active |
| 71335-0049-09 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-9) | 2012-04-12 | Active |
You're viewing one of 9 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-0049-07?
What is the difference between NDC 71335-0049-07 and NDC 71335-0049-04?
What NDC number is used to bill for this package of Diethylpropion Hydrochloride ER 75 mg Tablet, Extended Release?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of 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 divided by 2.2 = kg; inches x 0.0254 = meters. Body Mass Index (BMI), kg/m 2 Weight (pounds) Height (feet, inches) 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 usefulness of agents of this class (See CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.
Diethylpropion hydrochloride extended release tablets, 75 mg are indicated for use as monotherapy only.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Diethylpropion Hydrochloride Extended Release Tablets, 75 mg: One extended-release 75 mg tablet daily, swallowed whole, in midmorning. Geriatric use 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 (See PRECAUTIONS , Geriatric Use ).
⛔ Contraindications ▾
CONTRAINDICATIONS Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension (See PRECAUTIONS ). Agitated states. Patients with a history of drug abuse. Use in combination with other anorectic agents is contraindicated. During or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crises may result.
⚠️ Warnings ▾
WARNINGS Diethylpropion hydrochloride extended release tablets, 75 mg should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products. In a case-control epidemiological study, the use of anorectic agents, including diethylpropion, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than 3 months was associated with a 23-fold increase in the risk of developing pulmonary hypertension.
Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, diethylpropion hydrochloride extended release tablets, 75 mg should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.
Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. Valvulopathy has been very rarely reported with diethylpropion hydrochloride extended release tablets, 75 mg monotherapy, but the causal relationship remains uncertain.
The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect preexisting valvular heart diseases or pulmonary hypertension prior to initiation of diethylpropion hydrochloride extended release tablets, 75 mg treatment. Diethylpropion hydrochloride extended release tablets, 75 mg are not recommended in patients with known heart murmur or valvular heart disease.
Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with diethylpropion hydrochloride extended release tablets, 75 mg should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds, or as determined by the physician and patient). Diethylpropion hydrochloride extended release tablets, 75 mg are not recommended for patients who used any anorectic agents within the prior year.
If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Diethylpropion hydrochloride extended release tablets, 75 mg 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. Prolonged use of diethylpropion hydrochloride may induce dependence with withdrawal syndrome on cessation of therapy.
Hallucinations have occurred rarely following high doses of the drug. Several cases of toxic psychosis have been reported following the excessive use of the drug and some have been reported in which the recommended dose appears not to have been exceeded. Psychosis abated after the drug was discontinued.
When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Cardiovascular: Precordial pain, arrhythmia (including ventricular), ECG changes, tachycardia, elevation of blood pressure, palpitation and rare reports of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination, have been reported. Valvulopathy has been very rarely reported with diethylpropion hydrochloride extended release tablets, 75 mg monotherapy, but the causal relationship remains uncertain.
Central Nervous System: In a few epileptics an increase in convulsive episodes has been reported; rarely psychotic episodes at recommended doses; dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and cerebrovascular accident Gastrointestinal: Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation, other gastrointestinal disturbances Allergic: Urticaria, rash, ecchymosis, erythema Endocrine: Impotence, changes in libido, gynecomastia, menstrual upset Hematopoietic System: Bone marrow depression, agranulocytosis, leukopenia Miscellaneous: A variety of miscellaneous adverse reactions has been reported by physicians.
These include complaints such as dysuria, dyspnea, hair loss, muscle pain, increased sweating, and polyuria.
🔄 Drug Interactions ▾
Drug Interactions Because diethylpropion hydrochloride extended release tablets, 75 mg are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors (See CONTRAINDICATIONS ). Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated. Antidiabetic drug requirements (i.e., insulin) may be altered.
Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 1.6 times the human dose (based on mg/m 2 ) and have revealed no evidence of impaired fertility or harm to the fetus due to diethylpropion hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Spontaneous reports of congenital malformations have been recorded in humans, but no causal relationship to diethylpropion has been established. Non-Teratogenic Effects.
Abuse with diethylpropion hydrochloride during pregnancy may result in withdrawal symptoms in the human neonate.
🧒 Pediatric Use ▾
Pediatric Use Since safety and effectiveness in pediatric patients below the age of 16 have not been established, diethylpropion hydrochloride extended release tablets, 75 mg is not recommended for use in pediatric patients 16 years of age and under.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of diethylpropion hydrochloride extended release tablets, 75 mg did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.
🆘 Overdosage ▾
OVERDOSAGE Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, and mydriasis. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmias, hypertension or hypotension and circulatory collapse.
Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdose of pharmacologically similar compounds has resulted in convulsions, coma and death. The reported oral LD 50 for mice is 600 mg/kg, for rats is 250 mg/kg and for dogs is 225 mg/kg.
Management of acute diethylpropion hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Intravenous phentolamine has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates diethylpropion hydrochloride extended release tablets, 75 mg overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Diethylpropion hydrochloride is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Tolerance has been demonstrated with all drugs of this class in which these phenomena have been looked for.
Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. For example, other central nervous system actions or metabolic effects may be involved. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.
The magnitude of increased weight loss of drug-treated patients over placebo-treated patients averages some fraction of a pound a week. However, individual weight loss may vary substantially from patient to patient. 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 drug prescribed, such as the physician/investigator relationship, 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 in years, whereas most studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone is unknown. Diethylpropion is rapidly absorbed from the GI tract after oral administration and is extensively metabolized through a complex pathway of biotransformation involving N-dealkylation and reduction. Many of these metabolites are biologically active and may participate in the therapeutic action of diethylpropion hydrochloride extended release tablets, 75 mg.
Due to the varying lipid solubilities of these metabolites, their circulating levels are affected by urinary pH. Diethylpropion and/or its active metabolites are believed to cross the blood-brain barrier and the placenta. Diethylpropion and its metabolites are excreted mainly by the kidney.
It has been reported that between 75-106% of the dose is recovered in the urine within 48 hours after dosing. Using a phosphorescence assay that is specific for basic compounds containing benzoyl group, the plasma half-life of the aminoketone metabolites is estimated to be between 4 to 6 hours. The controlled-release characteristics of diethylpropion hydrochloride extended release tablets, 75 mg have been demonstrated by studies in humans in which plasma levels of diethylpropion-related materials were measured by phosphorescence analysis.
Plasma levels obtained with the diethylpropion hydrochloride extended release tablets, 75 mg formulation administered once daily indicated a more gradual release than the immediate-release formulation (three 25 mg tablets given in a single dose). Diethylpropion hydrochloride extended release tablets, 75 mg have not been shown superior in effectiveness to the same dosage of the immediate-release formulation (one 25 mg tablet three times daily). After administration of a single dose of diethylpropion hydrochloride extended release tablets, 75 mg (one 75 mg extended release tablet) or diethylpropion hydrochloride solution (75 mg dose) in a cross-over study using normal human subjects, the amount of parent compound and its active metabolites recovered in the urine within 48 hours for the…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Diethylpropion Hydrochloride Extended Release Tablets, 75 mg: Each white to off-white capsule-shaped tablet is debossed “LCI” on one side and “1477” on the other side. Product: 71335-0049 NDC: 71335-0049-1 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-2 28 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-3 90 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-4 7 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-5 14 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-6 84 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-7 21 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-8 60 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 71335-0049-9 45 TABLET, EXTENDED RELEASE in a BOTTLE Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
Keep tightly closed and protect from excessive heat. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are available for oral administration as extended release tablets containing 75 mg diethylpropion hydrochloride, USP. The inactive ingredients in each extended release tablet are: mannitol, carbomer homopolymer, tartaric acid, hydroxypropyl methylcellulose, povidone, and magnesium stearate. Diethylpropion hydrochloride is a sympathomimetic agent.
The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride. Its chemical structure is: In diethylpropion hydrochloride extended release tablets, 75 mg, diethylpropion hydrochloride is dispersed in a hydrophilic matrix. On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix.
The result is controlled release of the anorectic agent. molecular structure
💬 Information for Patients ▾
Information for Patient The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and diethylpropion hydrochloride extended release tablets, 75 mg (See WARNINGS ). The patient should be advised to observe caution when driving or engaging in any potentially hazardous activity.