Prescription medicine
Phendimetrazine
Phendimetrazine is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.132 per phendimetrazine 35 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule III
Check it at the source: the phendimetrazine FDA label on DailyMed (effective December 6, 2024, KVK-TECH, INC); the NDA 18074 record on Drugs@FDA; every phendimetrazine label on DailyMed.
Highlights of the record
FDA label of December 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePhendimetrazine tartrate is 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 who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
Forms and strengths
- 35 mg
- 105 mg
Tablet; extended-release capsule.
On the market
- Earliest approval on file
- April 16, 1979 Phendimetrazine Tartrate, Acertis Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 62 first October 20, 1975; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.132 per tablet Phendimetrazine 35 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 57 through July 30, 2026
What is phendimetrazine used for?
From the label: indications and usagePhendimetrazine tartrate is 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 who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. 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. […]
Conditions named in the indications of phendimetrazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sympathomimetic Amine Anorectic.
Source: FDA drug label (Phendimetrazine Tartrate), KVK-TECH, INC, effective December 6, 2024 (SPL set 07bf3488-09e7-436f-af3f-94c35a7be025), via openFDA; the full label on DailyMed
Is there a generic for phendimetrazine?
The FDA approved the first generic phendimetrazine on October 20, 1975. 62 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists phendimetrazine from 11 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 1975 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for phendimetrazine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.132 per Phendimetrazine 35 mg tablet, up 4% from $0.128 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Phendimetrazine 35 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Phendimetrazine 35 mg tablet | Generic | $0.132 per tablet | $3.96 | +4% |
| Phendimetrazine ER 105 mg capsule | Generic | $3.38 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $101.46 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the phendimetrazine label say about other medicines?
The phendimetrazine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fenfluramine | warnings | Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. |
Source: FDA drug label (Phendimetrazine Tartrate), KVK-TECH, INC, effective December 6, 2024 (SPL set 07bf3488-09e7-436f-af3f-94c35a7be025), via openFDA; the full label on DailyMed
What do FAERS reports show for phendimetrazine?
The FDA Adverse Event Reporting System holds 57 reports that list phendimetrazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as phendimetrazine?
7 other medicines are given the same way (oral) and in the same FDA class as phendimetrazine or labeled mainly for the same use (weight management), the same class first. Weight management lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Phentermine | Weight management | 27 labelers | $0.0727 per tablet 37.5 mg tablet | No current entry |
| Diethylpropion | Weight management | 13 labelers | $0.238 per tablet 25 mg tablet | No current entry |
| Phentermine and topiramate | Weight management | 2 labelers | $3.06 per capsule 7.5-46 mg capsule | No current entry |
| Benzphetamine | Weight management | 6 labelers | n/a | No current entry |
| Orforglipron | Weight management | none listed | $20.89 per tablet 0.8 mg tablet | No current entry |
| Orlistat | Weight management | none listed | $7.00 per capsule 120 mg capsule | No current entry |
| Bupropion and naltrexone | Weight management | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as phendimetrazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does phendimetrazine compare with medicines for the same use?
2 side-by-side pages set phendimetrazine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to phendimetrazine
- 7 medicines for the same use
- Other sympathomimetic amine anorectics
- the pharmacologic class, with prices and generics
- Phendimetrazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other