Prescription medicine

Benzphetamine First approved as Didrex

Benzphetamine (Didrex) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 6 generic labelers.

Generic listed
DEA Schedule III

Check it at the source: the benzphetamine FDA label on DailyMed (effective July 29, 2026, KVK-TECH, INC); the NDA 12427 record on Drugs@FDA; every benzphetamine label on DailyMed.

Highlights of the record

FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Forms and strengths

50 mg

Tablet; film-coated tablet.

On the market

Earliest approval on file: October 26, 1960 Didrex, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 9 first April 17, 2006; 4 with a marketed status in Drugs@FDA
Labelers listed (NDC): 6 of which 6 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2016 0 Class I among all firms' recalls; latest January 15, 2021
FAERS reports: 11 through July 30, 2026

What is benzphetamine used for?

From the label: indications and usage
Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 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 × 0.0254 = meters. […]

Conditions named in the indications of benzphetamine's FDA labels, with every medicine labeled for each:

Weight management

From other benzphetamine labels
Weight management: INDICATIONS AND USAGE Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial …

FDA pharmacologic class: Sympathomimetic Amine Anorectic.

Source: FDA drug label (BENZPHETAMINE HYDROCHLORIDE), KVK-TECH, INC, effective July 29, 2026 (SPL set 14d4589d-7f1c-4b6e-9557-59dad39b0960), via openFDA; the full label on DailyMed

Is there a generic for benzphetamine (Didrex)?

The FDA approved the first generic benzphetamine on April 17, 2006. 9 generic applications are approved; 4 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 benzphetamine from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1960 earliest approval on file
2006 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has benzphetamine been recalled?

The FDA's Enforcement Report lists 2 recalls naming benzphetamine since 2016: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
January 15, 2021	Class III	Calvin Scott & Company, Inc.	Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets …
May 5, 2016	Class III	KVK-Tech, Inc.	Discoloration: presence of scuffing marks on tablets.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the benzphetamine label say about other medicines?

The benzphetamine 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.

Check benzphetamine against other medicines

Source: FDA drug label (BENZPHETAMINE HYDROCHLORIDE), KVK-TECH, INC, effective July 29, 2026 (SPL set 14d4589d-7f1c-4b6e-9557-59dad39b0960), via openFDA; the full label on DailyMed

What do FAERS reports show for benzphetamine?

The FDA Adverse Event Reporting System holds 11 reports that list benzphetamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 4 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

Drug Ineffective (a use or a product term, not a reaction)4
Pyrexia2
Abdominal Pain1
Adverse Reaction (named in the label)1
Cerebrovascular Accident1
Decreased Appetite1
Drug Screen False Positive1
Energy Increased1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as benzphetamine?

7 other medicines are given the same way (oral) and in the same FDA class as benzphetamine 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
Phendimetrazine	Weight management	11 labelers	$0.132 per tablet 35 mg tablet	No current entry
Phentermine and topiramate	Weight management	2 labelers	$3.06 per capsule 7.5-46 mg capsule	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 benzphetamine

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to benzphetamine: 7 medicines for the same use
Other sympathomimetic amine anorectics: the pharmacologic class, with prices and generics
Benzphetamine side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other