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PHENDIMETRAZINE TARTRATE 35 mg Tablet, 100-count

by Virtus Pharmaceuticals, LLC · 100 TABLET in 1 BOTTLE (69543-410-10)
NDC 69543-0410-10
🏷️ FDA NDC (as labeled) 69543-410-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1329 NADAC Per package$13.29 / 100 tablets Pack sizes2 compare ↓
Also comes in: 1000 tablets 69543-0410-11
Rx only Generic On market CIII
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69543-410-10
Product NDC 69543-410
11-digit billing NDC 69543041010
NCPDP billing unit EA — each (per item)
RxCUI 979549
UNII 6985IP0T80
Application # ANDA085588
SPL Set ID cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2
Established class (EPC) Sympathomimetic Amine Anorectic
Physiologic effect Appetite Suppression; Increased Sympathetic Activity
DEA schedule CIII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-01
Route ORAL
Dosage form TABLET
Substance PHENDIMETRAZINE TARTRATE
GPI-14 61200050100305
GPI class Phendimetrazine Tartrate
GCN Seq No 005170
GCN 20852
HICL code 002115
Ingredient (HICL) Phendimetrazine Tartrate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J8
Therapeutic class — intermediate (HIC2) Anti-Obesity - Anorexics
HIC3 code J8A
Therapeutic class — specific (HIC3) Anti-Obesity - Anorexic Agents
AHFS code 28:20.08.04
AHFS class Amphetamine Derivatives
FDB label name PHENDIMETRAZINE 35 MG TABLET
FDB brand name Phendimetrazine Tartrate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69543-410-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69543-0410-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sympathomimetic Amine Anorectic class.

Pharmacologic class Sympathomimetic Amine Anorectic
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerVirtus Pharmaceuticals, LLC
Application holderACERTIS PHARMACEUTICALS LLC
FDA applicationANDA085588 (ANDA)
Labeler code69543
First marketedJul 2018
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHENDIMETRAZINE 35 MG TABLET Ingredient Phendimetrazine Tartrate
📗 Our plain-language guide HelloPharmacist
  • Phendimetrazine is a short-term prescription aid to help you lose weight when diet and exercise alone haven't been enough. It's a stimulant that works on your central nervous syste...
  • What exactly is phendimetrazine supposed to do for me?
  • It depends on which form you have. If you have the tablet, you'll generally take it about an hour before meals, two or three times a day. If you have the extended-release capsule,...
  • How do I take it — does it matter when during the day?
📖 Read our full Phendimetrazine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.133 $13.29 / 100 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Jan 2026 Aug 2026 $0.165 $0.125
▼ Down 5% over the last 22 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phendimetrazine Tartrate 35 mg 10702-0077-01 KVK-TECH, 100 tablets $0.133 AA Availability likely —
Phendimetrazine Tartrate 35 mg 64850-0440-01 Elite 100 tablets $0.133 AA Availability likely —
Phendimetrazine Tartrate 35 mgthis 69543-0410-10 Virtus 100 tablets $0.133 AA Availability likely —
Phendimetrazine Tartrate 35 mg 10702-0045-01 KVK-TECH, 100 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 10702-0078-01 KVK-TECH, 100 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 17224-0800-28 Calvin 28 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 43063-0510-07 PD-Rx 7 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 50090-0715-00 A-S 30 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 50090-2235-00 A-S 100 tablets — AA Discontinued —
Phendimetrazine Tartrate 35 mg 50090-6552-02 A-S 90 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 63629-2489-01 Bryant 1000 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 66267-0394-60 NuCare 60 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 68071-3509-06 NuCare 60 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 68071-3839-09 NuCare 90 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 68788-7236-01 Preferred 14 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 71335-0074-00 Bryant 120 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 71335-0324-00 Bryant 120 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 71335-1840-00 Bryant 120 tablets — AA FDA listed —
Phendimetrazine Tartrate 35 mg 72162-2044-00 Bryant 1000 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
69543-0410-10 You're viewing this 100 TABLET in 1 BOTTLE (69543-410-10) $0.1329 / ea $13.29 2018-07-01 Active
69543-0410-11 1000 TABLET in 1 BOTTLE (69543-410-11) $0.1329 / ea $132.85 2018-07-01 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1329 NADAC).

Pack size FAQ

What quantity is in NDC 69543-0410-10?
NDC 69543-0410-10 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 69543-0410-10 and NDC 69543-0410-11?
Both are PHENDIMETRAZINE TARTRATE 35 mg Tablet — the drug itself is identical. NDC 69543-0410-10 is the 100-count package, while NDC 69543-0410-11 is the 1000 tablets package.
What NDC number is used to bill for this package of PHENDIMETRAZINE TARTRATE 35 mg Tablet?
Bill NDC 69543-0410-10 — the 11-digit billing format is 69543041010. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 60 words ▾

INDICATIONS AND USAGE Phendimetrazine tartrate tablets 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. The limited 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.

⏱️ Dosage and Administration 50 words ▾

DOSAGE AND ADMINISTRATION Usual Adult Dose: 1 tablet (35 mg) b.i.d. or t.i.d., one hour before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets t.i.d.

⛔ Contraindications 41 words ▾

CONTRAINDICATIONS Known hypersensitivity or idiosyncratic reactions to sympathomimetics. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism and glaucoma. Highly nervous or agitated patients. Patients with a history of drug abuse. Patients taking other CNS stimulants, including monoamine oxidase inhibitors.

⚠️ Warnings 102 words ▾

WARNINGS Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded. Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.

Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine 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.

🤒 Adverse Reactions 42 words ▾

ADVERSE REACTIONS Cardiovascular: Palpitation, tachycardia, elevated blood pressure. Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain. Genitourinary: Urinary frequency, dysuria, changes in libido.

🤰 Pregnancy 45 words ▾

Usage in Pregnancy Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or who may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

🧒 Pediatric Use 17 words ▾

Usage in Children Phendimetrazine tartrate is not recommended for use in children under 12 years of age.

🆘 Overdosage 102 words ▾

OVERDOSAGE Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse.

Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Poisoning may result in convulsions, coma and death. The management of overdosage is largely symptomatic.

It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions 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.

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. Other central nervous system actions or metabolic effects, may be involved, for example.

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 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 drug 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 in 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.

📦 How Supplied / Storage and Handling 91 words ▾

HOW SUPPLIED Phendimetrazine Tartrate Tablet 35 mg is a yellow, bisected, round tablet; imprinted “E 76”. NDC 69543-410-10 bottles of 100 tablets NDC 69543-410-11 bottles of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight, light-resistant, container as defined in the USP, with a child-resistant closure (as required). To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by Virtus Pharmaceuticals, LLC Langhorne, PA 19047 Rev.

08/2023 MF4055REV08/23 OE2826

📋 Description 93 words ▾

DESCRIPTION Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2 s ,3 s ,)-3,4-dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is as follows: Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol; insoluble in chloroform, acetone, ether and benzene.

Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. Inactive Ingredients: confectioner’s sugar (sucrose and corn starch), lactose monohydrate, povidone, pregelatinized starch, silicon dioxide and stearic acid. The yellow tablets also contain: FD&C yellow No.

5 (see PRECAUTIONS ). chemical-structure.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69543-0107-10 · Virtus 69543-0417-10 · Virtus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.