NDC 67296-1205-04 — Dicloxacillin Sodium 500 mg Capsule, 40-count

🆔 Identity & classification

FDA NDC (as labeled) 67296-1205-4

Product NDC 67296-1205

11-digit billing NDC 67296120504

Application # ANDA061454

SPL Set ID 4f0941aa-8496-10d1-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 2023)

Route ORAL

Dosage form CAPSULE

Substance DICLOXACILLIN SODIUM

Why two NDCs? The FDA registers this code as 67296-1205-4 — a 5-4-1 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 package segment → 67296-1205-04. 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

LabelerRedPharm Drug, Inc.

Application holderCHARTWELL RX SCIENCES LLC

FDA applicationANDA061454 (ANDA)

Labeler code67296

Product typeHuman Prescription Drug

Portfolio26 products on file

🔎 All NDCs from RedPharm Drug, Inc.

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

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Dicloxacillin Sodium — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Dicloxacillin Sodium (56 interactions) — ranked by severity →

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.

BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion +3 more

🧪 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.

💊 What it looks like

Color blue

ShapeCapsule

ImprintGG855

Size22 mm

ScoringNot scored

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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 system	Per each	Per 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.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dicloxacillin Sodium 500 mgthis 67296-1205-04	RedPharm	40 capsules	—	—	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

Male · 39%

Female · 61%

Serious outcomes

Hospitalization82

Death31

Life-threatening22

Disabling18

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
67296-1205-04 You're viewing this	40 CAPSULE in 1 BOTTLE (67296-1205-4)	1971-04-01	Inactivated by FDA

🧭 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	✓ Available
Inactive ingredients (structured)	✓ 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 67296-1205-4, 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: 67296-1205-04, written without dashes as 67296120504. 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 67296-1205-04, the first segment (67296) is the labeler code FDA assigned to RedPharm Drug, Inc.; the middle segment (1205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.

Who lists this product with the FDA?

RedPharm Drug, 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 195 words ▾

INDICATIONS AND USAGE The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – SUSCEPTIBILITY TESTING). The penicillinase-resistant penicillins 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION 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 pa RECOMMENDED DOSAGES FOR DICLOXACILLIN SODIUM, USP IN MILD TO MODERATE AND SEVERE INFECTIONS DRUG ADULTS CHILDREN Mild to Moderate Severe Mild to Moderate Severe * Patients weighing less than 40 kg (88 lbs.) Dicloxacillin 125 mg every 6 hours 250 mg every 6 hours 12.5 mg/kg/ day* in equally divided doses every 6 hours 25 mg/kg/ day* in equally divided doses every 6 hours Dicloxacillin is best absorbed when taken on an empty stomach, and should be administered at least 1 hour before or 2 hours after meals.

Dicloxacillin should be taken with at least 4 fluid ounces (120 mL) of water and should not be taken in the supine position or immediately before going to bed (see PRECAUTIONS). renteral agent as soon as the clinical condition warrants.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Dicloxacillin sodium is contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.

⚠️ Warnings ~1 min read ▾

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 percent. Anaphylactic shock resulting in death has occurred in approximately 0.002 percent 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, dicloxacillin should be discontinued and appropriate therapy instituted.

Individuals with a history of penicillin hypersensitivity may also experience allergic reactions when treated with a cephalosporin. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including dicloxacillin sodium, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Hypersensitive Reactions The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (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 2 to 4 weeks after initiation of therapy.

Manifestations of this type of reaction include serum sickness-like symptoms (ie, fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Gastrointestinal Reactions Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy. Pseudomembranous colitis has been reported with the use of dicloxacillin.

Therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with dicloxacillin use. Reports have been received during postmarketing surveillance of esophageal burning, esophagitis, and esophageal ulceration, particularly after ingestion of dicloxacillin capsules with an insufficient quantity of water and/or before going to bed (see PRECAUTIONS and DOSAGE AND ADMINISTRATION). Nervous System Reactions Neurotoxic reactions similar to those observed with penicillin G (e.g., lethargy, confusion, twitching, multifocal myoclonus, localized or generalized epileptiform seizures) may occur with large intravenous doses of the penicillinase-resistant penicillins especially in patients with renal insufficiency.

Renal 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.

Hematologic Reactions Eosinophilia, hemolytic anemia, agranulocytosis, neutropenia, leukopenia, granulocytopenia, thrombocytopenia, and bone marrow depression have been associated with the use of penicillinase-resistant penicillins. Hepatic Reactions Hepatotoxicity, characterized by fever, nausea, and vomiting associated with abnormal liver function tests, mainly elevated AST (SGOT) levels, has been associated with the use of oxacillin and cloxacillin. Cholestatic hepatitis has been reported rarely.

Asymptomatic, transient increases in serum concentrations of alkaline phosphatase, AST (SGOT), and ALT (SGPT) have been reported.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Microbiology 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. 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.

Aerobic Gram-Positive Microorganisms: Staphylococcus spp. Susceptibility Testing: Susceptibility of staphylococcal isolates to dicloxacillin may be inferred by testing penicillin and either oxacillin or cefoxitin1. 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 Dicloxacillin sodium, USP is resistant to destruction by acid.

Absorption of dicloxacillin sodium after oral administration is rapid but incomplete. Food in the gastrointestinal tract decreases the absorption of dicloxacillin. Studies with an oral dose of 125 mg gave average serum levels at 60 minutes of 4.74 mcg/mL.

At four hours, average levels were 0.62 mcg/mL. In one study, single oral doses of dicloxacillin sodium 500 mg produced peak serum concentrations of 10 to 17 mcg/mL at 1 to 1.5 hours. Once absorbed, dicloxacillin sodium is 95% to 99% bound to serum proteins, mainly albumin.

Dicloxacillin sodium, with normal doses, has insignificant concentrations in the cerebrospinal and ascitic fluids. It is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. Dicloxacillin sodium is rapidly excreted as unchanged drug in the urine by glomerular filtration and active tubular secretion.

The elimination half-life for dicloxacillin sodium is about 0.7 hours. Dicloxacillin is not dialyzable. Only minimal amounts are removed by hemodialysis or peritoneal dialysis.

📦 How Supplied / Storage and Handling 69 words ▾

HOW SUPPLIED Dicloxacillin sodium capsules, USP 250 mg Light blue opaque cap/body capsule printed with GG854 containing dicloxacillin sodium, USP equivalent to 250 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2248-01 500 mg Light blue opaque cap/body capsule printed with GG855 containing dicloxacillin sodium, USP equivalent to 500 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2258-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 99 words ▾

DESCRIPTION Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium, USP is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula: [Dicloxacillin sodium chemical structure] Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 or 500 mg of dicloxacillin.

The inactive ingredient is magnesium stearate. The capsule shells contain FD&C Blue 1, titanium dioxide, and gelatin. The capsule ink contains shellac, propylene glycol, black iron oxide, ammonium hydroxide and potassium hydroxide

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

arthralgia: Joint pain.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

bactericidal: Describes a medicine that kills bacteria outright.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

edema: Swelling caused by extra fluid trapped in the body's tissues.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hematuria: Blood in the urine.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Inactive ingredient: A component of a medicine, such as a filler, binder, or dye, that does not produce the intended effect.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

laryngospasm: A sudden spasm of the vocal cords that briefly closes the voice box and makes it hard to breathe or speak.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

myalgia: Muscle pain or aching.

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

postmarketing surveillance: Tracking of a medicine's safety after it is approved and being used by the general public.

proteinuria: Protein leaking into the urine, which can be a sign that the kidneys' filters are damaged.

pruritus: Itching of the skin.

pseudomembranous colitis: A serious swelling of the large intestine, usually caused by C. difficile bacteria, that leads to severe diarrhea.

refractory: Describing a disease that does not respond to, or improve with, treatment.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

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

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