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Dicloxacillin Sodium 500 mg Capsule, 28-count

by NuCare Pharmaceticals, Inc. · 28 CAPSULE in 1 BOTTLE (66267-073-28)
NDC 66267-0073-28
🏷️ FDA NDC (as labeled) 66267-073-28 billing pads the product segment with a zero
This package
Contains28-count Pack sizes2 compare ↓
Also comes in: 30 capsules 66267-0073-30
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 17, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 66267-073-28
Product NDC 66267-073
11-digit billing NDC 66267007328
NCPDP billing unit EA — each (per item)
Application # ANDA062286
SPL Set ID 3dbcccb5-5a36-45cf-e054-00144ff8d46c
Chemical class Penicillin-class Antibacterial [EPC], Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form CAPSULE
Substance DICLOXACILLIN SODIUM
GCN Seq No 008984
GCN 39542
HICL code 003960
Ingredient (HICL) Dicloxacillin Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.12
AHFS class Penicillinase-Resistant Penicillins
FDB label name DICLOXACILLIN 500 MG CAPSULE
FDB brand name Dicloxacillin Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 66267-073-28 — 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 → 66267-0073-28. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceticals, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA062286 (ANDA)
Labeler code66267
Product typeHuman Prescription Drug
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 DICLOXACILLIN 500 MG CAPSULE Ingredient Dicloxacillin Sodium
📗 Our plain-language guide HelloPharmacist
  • Dicloxacillin is used specifically for staph (staphylococcal) infections caused by bacteria that have developed resistance to regular penicillin. These resistant staph bacteria pro...
  • What kind of infections does dicloxacillin actually treat?
  • Yes, it does matter. Food slows down how quickly your body absorbs dicloxacillin, which means the medicine may not work as well. Try to take it on an empty stomach — about 30 to 60...
  • Please don't stop early, even if you feel much better. With staph infections, stopping too soon can leave behind bacteria that come back stronger or harder to treat. For severe inf...
📖 Read our full Dicloxacillin guide →
8
Nutrient depletion considerations

Dicloxacillin Sodium may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dicloxacillin Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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.

💲 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: 30 capsules
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
Dicloxacillin Sodium 500 mg 00093-3125-01 Teva 100 capsules $1.012 AB Availability likely —
Dicloxacillin Sodium 500 mg 59651-0566-01 Aurobindo 100 capsules $1.012 AB Availability likely —
Dicloxacillin Sodium 500 mg 43063-0473-20 PD-Rx 20 capsules — AB FDA listed —
Dicloxacillin Sodium 500 mg 63629-4256-01 Bryant 20 capsules — AB FDA listed —
Dicloxacillin Sodium 500 mg 76420-0183-20 Asclemed 20 capsules — AB FDA listed —
Dicloxacillin Sodium 500 mgthis 66267-0073-28 NuCare 28 capsules — AB Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dicloxacillin Sodium — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dicloxacillin Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$250K
Claims incl. refills
5.5K
Beneficiaries
4.6K
Spend / beneficiary
$54.61
Spend / claim
$45.57
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dicloxacillin Sodium — the ingredient across all brands.

Top reported reactions

Abdominal Discomfort16
Arthralgia16
Drug Hypersensitivity16
Diarrhoea15
Headache15
Malaise15
Injury14

Age at onset

Neonate1
Infant1
Adolescent1
Adult18
Elderly13

Reporter sex

195 reports
Male · 39%
Female · 61%

Serious outcomes

Hospitalization82
Death31
Life-threatening22
Disabling18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 29 8
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
66267-0073-28 You're viewing this 28 CAPSULE in 1 BOTTLE (66267-073-28) 2016-09-30 Inactivated by FDA
66267-0073-30 30 CAPSULE in 1 BOTTLE (66267-073-30) 2016-09-30 Inactivated by FDA

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

Pack size FAQ

What quantity is in NDC 66267-0073-28?
NDC 66267-0073-28 is a 28-count package — 28 capsule in 1 bottle.
What is the difference between NDC 66267-0073-28 and NDC 66267-0073-30?
Both are Dicloxacillin Sodium 500 mg Capsule — the drug itself is identical. NDC 66267-0073-28 is the 28-count package, while NDC 66267-0073-30 is the 30 capsules package.
What NDC number is used to bill for this package of Dicloxacillin Sodium 500 mg Capsule?
Bill NDC 66267-0073-28 — the 11-digit billing format is 66267007328. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 66267-073-28, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 66267-0073-28, written without dashes as 66267007328. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 66267-0073-28, the first segment (66267) is the labeler code FDA assigned to NuCare Pharmaceticals, Inc.; the middle segment (0073) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (28) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (66267-0073-30). 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?
NuCare Pharmaceticals, Inc. 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.

📄 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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 196 words ▾

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules USP and other antibacterial drugs, dicloxacillin sodium capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Plate Testing ) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results.

The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Bacteriologic studies to determine the causative organisms and their sensitivity to the penicillinase-resistant penicillins should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with penicillinase-resistant penicillins should be continued for at least 14 days.

Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer term of therapy. Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels.

Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary. Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General ).

Oral therapy with the penicillinase-resistant penicillins may be used to follow up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

NB: INFECTIONS CAUSED BY GROUP A BETA-HEMOLYTIC STREPTOCOCCI SHOULD BE TREATED FOR AT LEAST 10 DAYS TO HELP PREVENT THE OCCURRENCE OF ACUTE RHEUMATIC FEVER OR ACUTE GLOMERULONEPHRITIS.

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

⚠️ Warnings 127 words ▾

WARNINGS Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions have occurred in patients receiving penicillin. The incidence of anaphylactic shock in all penicillin-treated patients is between 0.015% and 0.04%. Anaphylactic shock resulting in death has occurred in approximately 0.002% of the patients treated.

Although anaphylaxis is more frequent following a parenteral administration, it has occurred in patients receiving oral penicillins. When penicillin therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. If an allergic reaction occurs, the drug should be discontinued and the patient should receive supportive treatment, e.g., artificial maintenance of ventilation, pressor amines, antihistamines and corticosteroids.

Individuals with a history of penicillin hypersensitivity may also experience allergic reactions when treated with a cephalosporin.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Body as a Whole The reported incidence of allergic reactions to penicillin ranges from 0.7% to 10% (see WARNINGS ). Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk and vaccines.

Two types of allergic reactions to penicillin are noted clinically, immediate and delayed. Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse and death. Such immediate anaphylactic reactions are very rare (see WARNINGS ) and usually occur after parenteral therapy, but have occurred in patients receiving oral therapy.

Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus and fever. Although laryngeal edema, laryngospasm and hypotension occasionally occur, fatality is uncommon. Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as two to four weeks after initiation of therapy.

Manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy. Nervous System Reactions Neurotoxic reactions similar to those observed with penicillin G may occur with large intravenous doses of the penicillinase-resistant penicillins, especially with patients with renal insufficiency.

Urogenital Reactions Renal tubular damage and interstitial nephritis have been associated with the administration of methicillin sodium and, infrequently, with the administration of nafcillin and oxacillin. Manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria and renal insufficiency. Methicillin-induced nephropathy does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy.

Metabolic Reactions Agranulocytosis, neutropenia and bone marrow depression have been associated with the use of methicillin sodium and nafcillin. Hepatotoxicity, characterized by fever, nausea and vomiting associated with abnormal liver function tests, mainly elevated SGOT levels, has been associated with the use of oxacillin. RECOMMENDED DOSAGES FOR DICLOXACILLIN IN MILD TO MODERATE AND SEVERE INFECTIONS DRUG ADULTS CHILDREN Mild to Moderate Severe Mild to Moderate Severe Dicloxacillin 125 mg every 250 mg every 12.5 mg/kg/day Patients weighing less than 40 kg (88 lbs) 25 mg/kg/day 6 hours 6 hours in equally in equally divided doses divided doses every 6 hours every 6 hours

🔄 Drug Interactions 22 words ▾

Drug Interactions Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.

🤰 Pregnancy 95 words ▾

Pregnancy Category B Reproduction studies performed in the mouse, rat and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to the penicillinase-resistant penicillins. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate or well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 64 words ▾

Pediatric Use Because of incompletely developed renal function in newborns, penicillinase-resistant penicillins (especially methicillin) may not be completely excreted, with abnormally high blood levels resulting. Frequent monitoring of blood levels is advisable in this group, with dosage adjustments when necessary. All newborns treated with penicillins should be monitored closely for clinical and laboratory evidence of toxic or adverse effects (see DOSAGE AND ADMINISTRATION ).

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Microbiology Mechanism of Action Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during the state of active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall. Antibacterial Activity Dicloxacillin sodium has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive Bacteria Staphylococcus spp. Susceptibility Test Methods Susceptibility of staphylococcal isolates to dicloxacillin may be inferred by testing penicillin and either oxacillin or cefoxitin 1 . For staphylococcal isolates, penicillin susceptibility implies susceptibility to other β-lactam agents, and penicillin resistance implies resistance to penicillinase-labile penicillins.

Resistance to oxacillin (or cefoxitin) implies resistance to all other β-lactam agents, except newer agents with activity against methicillin-resistant Staphylococcus aureus . Routine testing of dicloxacillin is not advised. Pharmacokinetics Methicillin sodium is readily destroyed by gastric acidity and must be administered by intramuscular or intravenous injection.

The isoxazolyl penicillins (cloxacillin, dicloxacillin and oxacillin) and nafcillin are more acid-resistant and may be administered orally. Absorption of the isoxazolyl penicillins after oral administration is rapid but incomplete; peak blood levels are achieved in 1 to 1.5 hours. In one study, after ingestion of a single 500 mg oral dose, peak serum concentrations range from 5 to 7 micrograms/milliliter for oxacillin, from 7.5 to 14.4 mcg/mL for cloxacillin and from 10 to 17 mcg/mL for dicloxacillin.

Oral absorption of cloxacillin, dicloxacillin, oxacillin and nafcillin is delayed when the drugs are administered after meals. Once absorbed, the penicillinase-resistant penicillins bind to serum protein, mainly albumin. The degree of protein binding reported varies with the method of study and the investigator (see TABLE II ).

TABLE II PENICILLINASE-RESISTANT PENICILLINS PERCENT PROTEIN BINDING ± SD Methicillin 37.3 ±

7.9Nafcillin 89.9 ±

1.5Oxacillin 94.2 ±

2.1Cloxacillin 95.2 ±

0.5Dicloxacillin 97.9 ±

0.6The penicillinase-resistant penicillins vary in the extent to which they are distributed in the body fluids. With normal doses, insignificant concentrations are found in the cerebrospinal fluid and aqueous humor. All the drugs in this class are found in therapeutic concentrations in the pleural, bile and amniotic fluids.

The penicillinase-resistant penicillins are rapidly excreted, primarily as unchanged drug in the urine by glomerular filtration and active tubular secretion. The elimination half-life for dicloxacillin is about 0.7 hour. Nonrenal elimination includes hepatic inactivation and excretion in bile.

📦 How Supplied / Storage and Handling 97 words ▾

HOW SUPPLIED Dicloxacillin sodium capsules USP are available as follows: 500 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 500 mg dicloxacillin (anhydrous), with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3125” on the body, available in bottles of 28 (NDC 66267-073-28) and bottles of 30 (NDC 66267-073-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 Description 73 words ▾

DESCRIPTION Dicloxacillin sodium USP is a semisynthetic antibiotic substance which resists destruction by the enzyme penicillinase (beta - lactamase). It is monosodium (2 S ,5 R ,6 R )-6-[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate. Dicloxacillin is administered orally via capsule form or powder for reconstitution.

Structurally, dicloxacillin sodium USP may be represented as follows: C 19 H 16 Cl 2 N 3 NaO 5 S·H 2 O MW 510.32 Structural formula for dicloxacillin sodium Inactive Ingredients

💬 Information for Patients ~2 min read ▾

Information for the Patient Patients should be counselled that antibacterial drugs including dicloxacillin sodium capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When dicloxacillin sodium capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by dicloxacillin sodium capsules or other antibacterial drugs in the future. Patients receiving penicillins should be given the following information and instructions by the physician: Patients should be told that penicillin is an antibacterial agent which will work with the body’s natural defenses to control certain types of infections.

They should be told that the drug should not be taken if they have had an allergic reaction to any form of penicillin previously, and to inform the physician of any allergies or previous allergic reactions to any drugs they may have had (see WARNINGS ). Patients who have previously experienced an anaphylactic reaction to penicillin should be instructed to wear a medical identification tag or bracelet. Because most antibacterial drugs taken by mouth are best absorbed on an empty stomach, patients should be directed, unless circumstances warrant otherwise, to take penicillin one hour before meals or two hours after eating (see CLINICAL PHARMACOLOGY - Pharmacokinetics ).

Patients should be told to take the entire course of therapy prescribed, even if fever and other symptoms have stopped (see PRECAUTIONS - General ). If any of the following reactions occur, stop taking your prescription and notify the physician: shortness of breath, wheezing, skin rash, mouth irritation, black tongue, sore throat, nausea, vomiting, diarrhea, fever, swollen joints or any unusual bleeding or bruising (see ADVERSE REACTIONS ). Do not take any additional medications without physician approval, including nonprescription drugs such as antacids, laxatives or vitamins.

Discard any liquid forms of penicillin after seven days if stored at room temperature or after 14 days if refrigerated.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 66267-0071-14 · NuCare 66267-0081-30 · NuCare →
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.