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Phentermine Hydrochloride 37.5 mg Tablet, 60-count — NDC 63187-0800-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Phentermine Hydrochloride 37.5 mg Tablet, 60-count — NDC 63187-800-60 (Billing 63187-0800-60)

by Proficient Rx LP · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Phentermine Hydrochloride 37.5 mg Tablet from Proficient Rx LP, marketed since Jun 2011 and currently FDA-listed.

NDC 63187-0800-60
🏷️ FDA NDC (as labeled) 63187-800-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes5 compare ↓
Product page 63187-0800-07 Also comes in: 7 tablets 63187-800-07 14 tablets 63187-800-14 15 tablets 63187-800-15 30 tablets 63187-800-30
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Other active recalls for Phentermine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 9, 2025 — cGMP deviations (KVK Tech, Inc.) · FDA recall D-0446-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-800-60
Product NDC 63187-800
11-digit billing NDC 63187080060
RxCUI 803353
UNII 0K2I505OTV
UPC 0363187800307
Application # ANDA203068
SPL Set ID b3c48b3c-fab7-4ea4-93b0-b108979e9da3
Established class (EPC) Sympathomimetic Amine Anorectic
Physiologic effect Appetite Suppression; Increased Sympathetic Activity
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-06-10
Route ORAL
Dosage form TABLET
Substance PHENTERMINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 61200070100310
GPI class Phentermine HCl
GCN Seq No 005159
GCN 20713
HICL code 002111
Ingredient (HICL) Phentermine Hcl
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 PHENTERMINE 37.5 MG TABLET
FDB brand name Phentermine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005159
  • GCN: 20713
  • GPI-14 (Medi-Span): 61200070100310
  • HICL (First Databank): 002111
  • AHFS class code: 28:20.08.04
  • RxCUI (RxNorm): 803353
Why two NDCs? The FDA registers this code as 63187-800-60 — 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 → 63187-0800-60. 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
Drug family (ATC) Centrally acting antiobesity products
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.

Clinical

Label name PHENTERMINE 37.5 MG TABLET Ingredient Phentermine Hcl
📖 What it is MedlinePlus · NLM

Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet. Phentermine is in a class of medications called anorectics. It works by decreasing appetite.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a short-term helper, for a few weeks, alongside diet, exercise and behavior changes. It's for adults with a BMI of 30 or more, or 27 or more if you also have things like contr...
  • It's taken by mouth, usually once a day around breakfast, with or without food on most labels. One brand, Lomaira, is taken more than once a day before meals. Avoid late-evening do...
  • Dry mouth, a bad taste, trouble sleeping, restlessness, headache, dizziness and stomach upset are common. Some people notice a faster heartbeat or higher blood pressure. Mention an...
  • Call if you have new shortness of breath, chest pain, fainting or swelling in your legs, since these can signal rare lung or heart problems. Also call for a racing or irregular hea...
📖 Read our full Phentermine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 7 tablets 14 tablets 15 tablets 30 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0800-07 63187-800-07 Main listing 7 TABLET in 1 BOTTLE 2017-01-02 — Active
63187-0800-14 63187-800-14 14 TABLET in 1 BOTTLE 2021-06-29 — Active
63187-0800-15 63187-800-15 15 TABLET in 1 BOTTLE 2017-01-02 — Active
63187-0800-30 63187-800-30 30 TABLET in 1 BOTTLE 2017-01-02 — Active
63187-0800-60 You're viewing this 60 TABLET in 1 BOTTLE 2017-01-02 — Active

You're viewing the largest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle.
How does this package differ from NDC 63187-0800-07?
Both are Phentermine Hydrochloride 37.5 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 63187-0800-07 is the 7 tablets package.
What NDC number is used to bill for this package of Phentermine Hydrochloride 37.5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phentermine Hydrochloride 37.5 mg 51224-0101-50 TAGI 100 tablets $0.070 AA FDA listed —
Phentermine Hydrochloride 37.5 mg 10702-0025-01 KVK-TECH, 100 tablets $0.073 AA Availability likely —
Phentermine hydrochloride 37.5 mg 11534-0160-01 SUNRISE 100 tablets $0.073 AA Availability likely —
Phentermine Hydrochloride 37.5 mg 53489-0676-01 Sun 100 tablets $0.073 AA Availability likely —
Phentermine Hydrochloride 37.5 mg 64850-0810-01 Elite 100 tablets $0.073 AA Availability likely —
Phentermine Hydrochloride 37.5 mg 13107-0061-01 Aurolife 100 tablets $0.104 AA FDA listed —
Phentermine Hydrochloride 37.5 mg 17224-0901-07 Calvin 7 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 17224-0902-07 Calvin 7 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 17224-0904-07 Calvin 7 tablets — AA FDA listed —
Phentermine HCL 37.5 mg 17224-0905-14 Calvin 14 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 17224-0907-07 Calvin 7 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 43063-0596-01 PD-Rx 100 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 43547-0404-03 Solco 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 50090-1498-00 A-S 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 50090-1679-00 A-S 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 51655-0875-24 Northwind 30 tablets — AA Discontinued —
Phentermine hydrochloride 37.5 mg 52605-0022-01 POLYGEN 100 tablets — AA Discontinued —
Phentermine Hydrochloride 37.5 mg 55289-0701-07 PD-Rx 7 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mgthis 63187-0800-60 Proficient 60 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 63629-1106-01 Bryant 100 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 63629-1107-01 Bryant 1000 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 63629-1108-01 Bryant 30 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 63629-2388-01 Bryant 1000 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 63629-2389-01 Bryant 100 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 63629-2477-01 Bryant 100 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 63629-4385-01 Bryant 7 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 68071-3663-03 NuCare 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 68071-3808-01 NuCare 100 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 68071-3819-01 NuCare 1000 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 68094-0702-50 Precision 100 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 68788-7906-01 Preferred 7 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 71205-0668-14 Proficient 14 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 71205-0758-14 Proficient 14 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 71335-0161-00 Bryant 90 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 71335-0350-00 Bryant 90 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 71335-1312-01 Bryant 30 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 71335-2297-01 Bryant 1000 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 71335-2488-00 Bryant 90 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 71335-3107-00 Bryant 90 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 72162-1229-00 Bryant 1000 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 72162-1562-00 Bryant 1000 tablets — AA FDA listed —
Phentermine Hydrochloride 30 mg 72162-1628-00 Bryant 1000 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 72189-0203-30 DIRECT 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 72189-0301-14 DirectRx 14 tablets — AA FDA listed —
Phentermine HCL C-IV 37.5 mg 72189-0669-30 Direct_Rx 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 72789-0433-14 PD-Rx 14 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 72789-0560-28 PD-Rx 28 tablets — AA FDA listed —
Phentermine hydrochloride 37.5 mg 76420-0108-30 Asclemed 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 84053-0025-07 Martek 7 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 82868-0053-30 Northwind 30 tablets — AA FDA listed —
Phentermine Hydrochloride 37.5 mg 82868-0112-30 Northwind 30 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

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 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.

What it looks like

Color White
ShapeCapsule
ImprintU40
Size1 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA203068 (ANDA)
Labeler code63187
First marketedJun 2011
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio1,729 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS & USAGE Phentermine hydrochloride tablets USP are indicated as 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 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. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight (pounds) 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 limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below.

Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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). ( 1 ) The limited usefulness of agents of this class, including phentermine hydrochloride tablets USP, should be measured against possible risk factors inherent in their use.

( 1 )

⏱️ Dosage and Administration 116 words ▾

2 DOSAGE & ADMINISTRATION Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Phentermine is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia. • Dosage should be individualized to obtain an adequate response with the lowest effective dose. ( 2 ) • Late evening administration should be avoided (risk of insomnia). ( 2 ) • Phentermine hydrochloride tablets can be taken with or without food ( 12.3 )

💊 Dosage Forms and Strengths 61 words ▾

3 DOSAGE FORMS & STRENGTHS Phentermine hydrochloride tablets are white to off-white with blue specks, capsule shaped, uncoated tablets, debossed with “U40” on one side and break line on the other side, containing 37.5 mg phentermine hydrochloride USP (equivalent to 30 mg phentermine base). • Tablets containing 37.5 mg phentermine hydrochloride USP (equivalent to 30 mg phentermine base). ( 3 )

⛔ Contraindications 159 words ▾

4 CONTRAINDICATIONS • History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) • During or within 14 days following the administration of monoamine oxidase inhibitors • Hyperthyroidism • Glaucoma • Agitated states • History of drug abuse • Pregnancy [see Use in Specific Populations ( 8.1 ) ] • Nursing [see Use in Specific Populations ( 8.3 ) ] • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines • History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) ( 4 ) • During or within 14 days following the administration of monoamine oxidase inhibitors ( 4 ) • Hyperthyroidism ( 4 ) • Glaucoma ( 4 ) • Agitated states ( 4 ) • History of drug abuse ( 4 ) • Pregnancy ( 4 , 8.1 ) • Nursing ( 4 , 8.3 ) • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). ( 5.1 ) • Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.

( 5.2 ) • Rare cases of serious regurgitant cardiac valvular disease have been reported. ( 5.3 ) • Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued.

The recommended dose should not be exceeded. ( 5.4 ) • Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. ( 5.5 ) • Risk of abuse and dependence.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. ( 5.6 ) • Concomitant alcohol use may result in an adverse drug reaction. ( 5.7 ) • Use caution in patients with even mild hypertension (risk of increase in blood pressure).

( 5.8 ) • A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. ( 5.9 )

5.1Coadministration with Other Drug Products for Weight Loss Phentermine hydrochloride tablets are 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.

5.2Primary Pulmonary Hypertension 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.

5.3Valvular Heart Disease 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.

5.4Development of Tolerance, Discontinuation in Case of Tolerance 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.

5.5Effect on the Ability to Engage in Potentially Hazardous Tasks 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.

5.6Risk of Abuse and Dependence Phentermine is re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 169 words ▾

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Primary pulmonary hypertension [see Warnings and Precautions ( 5.2 ) ] - Valvular heart disease [see Warnings and Precautions ( 5.3 ) ] - Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions ( 5.5 ) ] - Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence ( 9.3 ) ] 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. Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. ( 6 )To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 128 words ▾

7 DRUG INTERACTIONS • Monoamine oxidase inhibitors: Risk of hypertensive crisis. ( 4 , 7.1 ) • Alcohol: Consider potential interaction ( 7.2 ) • Insulin and oral hypoglycemics: Requirements may be altered. ( 7.3 ) • Adrenergic neuron blocking drugs: Hypotensive effect may be decreased by phentermine. ( 7.4 )

7.1Monoamine Oxidase Inhibitors Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

7.2Alcohol Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

7.3Insulin and Oral Hypoglycemic Medications Requirements may be altered [see Warnings and Precautions ( 5.9 ) ].

7.4Adrenergic Neuron Blocking Drugs Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. ( 4 , 8.3 ) • Pediatric use: Safety and effectiveness not established. ( 8.4 ) • Geriatric use: Due to substantial renal excretion, use with caution. ( 8.5 ) • Use caution when administering phentermine to patients with renal impairment ( 8.6 )

8.1Pregnancy 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.

8.3Nursing Mothers 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.

8.4Pediatric Use 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.

8.5Geriatric Use 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.

8.6Renal Impairment Phentermine was not studied in patients with renal impairment. Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment [see Clinical Pharmacology ( 12.3 ) ].

🤰 Pregnancy 117 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 35 words ▾

8.4Pediatric Use 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.

🧓 Geriatric Use 99 words ▾

8.5Geriatric Use 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 185 words ▾

10 OVERDOSAGE The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

10.1Acute 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.

10.2Chronic Intoxication 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 ) .

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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.

12.2Pharmacodynamics 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.

12.3Pharmacokinetics 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 Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62% to 85%. Exposure increases can be expected in patients with renal impairment.

Use caution when administering phentermine to patients with renal impairment.

🧬 Mechanism of Action 74 words ▾

12.1Mechanism of Action 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.

📦 How Supplied / Storage and Handling 111 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Available as tablets containing 37.5 mg phentermine hydrochloride USP (equivalent to 30 mg phentermine base). Phentermine hydrochloride tablets, USP are supplied as white to off-white with blue specks, capsule shaped, uncoated tablets, debossed with “U40” on one side and break line on the other side. Bottles of 07 NDC 63187-800-07 Bottles of 14 NDC 63187-800-14 Bottles of 15 NDC 63187-800-15 Bottles of 30 NDC 63187-800-30 Bottles of 60 NDC 63187-800-60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Keep out of the reach of children.

📋 Description 104 words ▾

11 DESCRIPTION Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Its chemical name is a,a-dimethylphenethylamine hydrochloride. The structural formula is as follows: Phentermine hydrochloride USP 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 tablets USP are available as an oral tablet containing 37.5 mg of phentermine hydrochloride USP (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet USP also contains the inactive ingredients microcrystalline cellulose, pregelatinized starch, anhydrous lactose, crospovidone, colloidal silicon dioxide, magnesium stearate, sucrose, corn starch and FD&C Blue #1. Phentermine hydrochloride Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION 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 ) ].

Advise 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: • Development of primary pulmonary hypertension [see Warnings and Precautions ( 5.2 ) ] • Development of serious valvular heart disease [see Warnings and Precautions ( 5.3 ) ] • Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions ( 5.5 ) ] • The risk of an increase in blood pressure [see Warnings and Precautions ( 5.8 ) and Adverse Reactions ( 6 ) ] • The risk of interactions [see Contraindications ( 4 ), Warnings and Precautions ( 5 ) and Drug Interactions ( 7 ) ] See also, for example, Adverse Reactions ( 6 ) and Use in Specific Populations ( 8 ) .

The patients must also be informed about • the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions ( 5.4 ) ] and • the risk of dependence and the potential consequences of abuse [see Warnings and Precautions ( 5.6 ), Drug Abuse and Dependence ( 9 ), and Overdosage ( 10 ) ]. 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.

Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 05/2014

🍼 Nursing Mothers 58 words ▾

8.3Nursing Mothers 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.

🧬 Pharmacokinetics 139 words ▾

12.3Pharmacokinetics 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 Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62% to 85%. Exposure increases can be expected in patients with renal impairment.

Use caution when administering phentermine to patients with renal impairment.

🧬 Pharmacodynamics 36 words ▾

12.2Pharmacodynamics 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.

🔬 Clinical Studies 202 words ▾

14 CLINICAL STUDIES 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.

🔒 Drug Abuse and Dependence 151 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Phentermine is a Schedule IV controlled substance.

9.2Abuse 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.

9.3Dependence 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 than 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.

🔒 Controlled Substance 10 words ▾

9.1Controlled Substance Phentermine is a Schedule IV controlled substance.

🧪 Nonclinical Toxicology 27 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

📄 Package Label / Principal Display Panel 24 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 37.5 mg (30 Tablets Bottle) NDC 63187-800-30 Phentermine Hydrochloride Tablets, USP CIV 37.5 mg Rx only 30 Tablets 63187-800-30

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 7 tablets (63187-0800-07), 14 tablets (63187-0800-14), 15 tablets (63187-0800-15). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63187-0799-14 · Proficient 63187-0801-30 · Proficient →
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.