HomeNDC LookupIngredientsPenicillin V Potassium › 00093-4125-73
Penicillin V Potassium 125 mg/5mL Powder, For Solution, 100 mL — NDC 00093-4125-73 package photo

Penicillin V Potassium 125 mg/5mL Powder, For Solution, 100 mL

by Teva Pharmaceuticals USA, Inc. · 100 mL in 1 BOTTLE (0093-4125-73)
NDC 00093-4125-73
🏷️ FDA NDC (as labeled) 0093-4125-73 billing pads the labeler segment with a zero
This package
Contains100 mL Cost per mL$0.0781 NADAC Per package$7.81 / 100 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0945/unit · Part D plans $0.0699/unit — full pricing hub ↓
Also comes in: 200 ml 00093-4125-74
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0093-4125-73
Product NDC 0093-4125
11-digit billing NDC 00093412573
NCPDP billing unit ML — per mL (volume)
UNII 146T0TU1JB
UPC 0300934125733, 0300931172013, 0300934127737
Application # ANDA060456
SPL Set ID 3111ca84-6f8e-45ea-91a1-9cb99c63607e
Established class (EPC) Penicillin-class Antibacterial
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-30
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance PENICILLIN V POTASSIUM
GPI-14 01100040102105
GCN Seq No 008876
GCN 39022
HICL code 003942
Ingredient (HICL) Penicillin V Potassium
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 08:12.16.04
AHFS class Natural Penicillin Antibiotics
FDB label name PENICILLIN VK 125 MG/5 ML SOLN
FDB brand name Penicillin V Potassium
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0093-4125-73 — a 4-4-2 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 labeler segment → 00093-4125-73. 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 Penicillin-class Antibacterial class.

Pharmacologic class Penicillin-class Antibacterial
Drug family (ATC) Beta-lactamase sensitive penicillins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA060456 (ANDA)
Labeler code00093
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio504 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PENICILLIN VK 125 MG/5 ML SOLN Ingredient Penicillin V Potassium
📖 What it is MedlinePlus · NLM

Penicillin V potassium is used to treat certain infections caused by bacteria such as pneumonia and other respiratory tract infections, scarlet fever, and ear, skin, gum, mouth, and throat infections prevent rheumatic fever (a serious illness that can happen after strep throat or scarlet fever and can damage the heart) from coming back Penicillin V potassium is in a class of medications called penicillins. It works by killing bacteria. Antibiotics such as penicillin V potassium will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increase...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used for mild to moderately severe bacterial infections — things like strep throat, scarlet fever, certain respiratory infections from pneumococcal bacteria, mild skin infecti...
  • What kinds of infections does Penicillin V Potassium actually treat?
  • You can take it either way — it won't upset most people's stomachs badly. That said, your body actually absorbs slightly more of the medication if you take it on an empty stomach....
  • Should I take it with food or on an empty stomach?
📖 Read our full Penicillin V Potassium guide →
7
Nutrient depletion considerations

Penicillin V Potassium may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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 white
ShapeOval
Imprint9;3;1174
Size17 mm
ScoringScored — splits in 2
FlavorCherry
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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

4 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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.078 $7.81 / 100 ml
Medicaid paysCMS SDUD · 12 mo $0.0945 $9.45 / 100 ml
Medicare drug plans payPart D · Q2 2026 $0.0699 $6.99 / 100 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Feb 2026 May 2026 Aug 2026 $0.079 $0.056
▲ Up 2% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Penicillin V Potassium 125 mg/5mLthis 00093-4125-73 Teva 100 ml $0.078 Availability likely
Penicillin V Potassium 125 mg/5mL 68788-9853-01 Preferred 100 ml FDA listed
Penicillin V Potassium 125 mg/5mL 62135-0102-01 Chartwell 100 ml 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00093-4125-73, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
8K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$127.8K
Avg / prescription
$15.96
Avg / unit
$0.0945
Latest quarter Q4 2025
1.3KRx
Medicaid pays / mL
$0.0945
gross reimbursed
vs
NADAC / mL
$0.0781
acquisition cost
=
Spread
+$0.0164
+21% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
35% FFS 65% MCO
Fee-for-service · 2,781 Rx Managed care · 5,228 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 5,000 units · 64.0 per 100k residents WA Idaho: no data reported ID Montana: 2,400 units · 212 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 23,800 units · 403 per 100k residents WI Michigan: 26,000 units · 259 per 100k residents MI New York: 149,510 units · 764 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 18,200 units · 570 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 10,800 units · 337 per 100k residents IA Illinois: 47,700 units · 380 per 100k residents IL Indiana: 80,500 units · 1,173 per 100k residents IN Ohio: 10,300 units · 87.4 per 100k residents OH Pennsylvania: 21,030 units · 162 per 100k residents PA New Jersey: 58,000 units · 624 per 100k residents NJ Massachusetts: 36,900 units · 527 per 100k residents MA California: 136,321 units · 350 per 100k residents CA Utah: no data reported UT Colorado: 1,700 units · 28.9 per 100k residents CO Nebraska: no data reported NE Missouri: 39,000 units · 629 per 100k residents MO Kentucky: 15,000 units · 331 per 100k residents KY West Virginia: no data reported WV Virginia: 12,020 units · 138 per 100k residents VA Maryland: 88,400 units · 1,430 per 100k residents MD Connecticut: 3,200 units · 88.5 per 100k residents CT Rhode Island: 6,900 units · 630 per 100k residents RI Arizona: 25,200 units · 339 per 100k residents AZ New Mexico: no data reported NM Kansas: 3,600 units · 122 per 100k residents KS Arkansas: 9,800 units · 320 per 100k residents AR Tennessee: 2,900 units · 40.7 per 100k residents TN North Carolina: 56,800 units · 524 per 100k residents NC South Carolina: 20,300 units · 378 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 76,300 units · 1,668 per 100k residents LA Mississippi: 19,300 units · 656 per 100k residents MS Alabama: 48,000 units · 940 per 100k residents AL Georgia: 124,300 units · 1,127 per 100k residents GA D.C.: 21,000 units · 3,093 per 100k residents DC Hawaii: no data reported HI Texas: 74,500 units · 244 per 100k residents TX Florida: 77,400 units · 342 per 100k residents FL
Units reimbursed · per 100k residents
28.93,093
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 3,093 /100k
2 Louisiana 1,668 /100k
3 Maryland 1,430 /100k
4 Indiana 1,173 /100k
5 Georgia 1,127 /100k
6 Alabama 940 /100k
7 New York 764 /100k
8 Mississippi 656 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 ml this page00093-4125-73 8,009 Rx · $127,833
2 ml00093-4125-74 4,189 Rx · $70,818
Drug total (last 4 qtrs): 12,198 Rx · 2,284,113 units · $198,651 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Penicillin V Potassium — the program that covers self-administered drugs. 5 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 Penicillin V Potassium. 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
$642.3K
Claims incl. refills
97K
Beneficiaries
84.2K
Spend / beneficiary
$7.63
Spend / claim
$6.62
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 Penicillin V Potassium — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity467
Dyspnoea220
Anxiety180
Hypersensitivity155
Condition Aggravated148
Asthma146
Fatigue142

Age at onset

Neonate7
Infant4
Child12
Adolescent15
Adult246
Elderly132

Reporter sex

2,540 reports
Male · 39%
Female · 61%
Unknown · 1%

Serious outcomes

Hospitalization656
Death189
Life-threatening165
Disabling50
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 282 0
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 Per unit Per pack Marketing startStatus
00093-4125-73 You're viewing this 100 mL in 1 BOTTLE (0093-4125-73) $0.0781 / mL $7.81 1990-09-30 Active
00093-4125-74 200 mL in 1 BOTTLE (0093-4125-74) $0.0499 / mL $9.97 1990-09-30 Active

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

Per mL, this pack runs about 57% above the cheapest pack (200 mL, $0.0499 vs $0.0781 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 66% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00093-4125-73?
NDC 00093-4125-73 contains 100 mL — 100 ml in 1 bottle.
What is the difference between NDC 00093-4125-73 and NDC 00093-4125-74?
Both are Penicillin V Potassium 125 mg/5mL Powder, For Solution — the drug itself is identical. NDC 00093-4125-73 is the 100 mL package, while NDC 00093-4125-74 is the 200 ml package. Per-mL NADAC also differs: $0.0781 here vs $0.0499 for the 200 ml pack.
What NDC number is used to bill for this package of Penicillin V Potassium 125 mg/5mL Powder, For Solution?
Bill NDC 00093-4125-73 — the 11-digit billing format is 00093412573. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE Penicillin V potassium tablets and penicillin V potassium for oral solution are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage.

Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal infections (without bacteremia).

Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant.

Pneumococcal infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections —penicillin G-sensitive.

Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent's gingivitis and pharyngitis)—Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin.

NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.

1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen.

NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1 To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium tablets, penicillin V potassium for oral solution, and other antibacterial drugs, penicillin V potassium tablets and penicillin V potassium for oral solution 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 ~2 min read

DOSAGE AND ADMINISTRATION The dosage of penicillin V potassium tablets and penicillin V potassium for oral solution should be determined according to the sensitivity of the causative microorganisms and the severity of infection, and adjusted to the clinical response of the patient. The usual dosage recommendations for adults and children 12 years and over are as follows: Streptococcal infections —mild to moderately severe—of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.

Pneumococcal infections —mild to moderately severe—of the respiratory tract, including otitis media: 250 to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days. Staphylococcal infections —mild infections of skin and soft tissue (culture and sensitivity tests should be performed): 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours. Fusospirochetosis (Vincent’s infection) of the oropharynx.

Mild to moderately severe infections: 250 to 500 mg (400,000 to 800,000 units) every 6 to 8 hours. For the prevention of recurrence following rheumatic fever and/or chorea: 125 to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis. For prophylaxis against bacterial endocarditis 1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs.) 6 hours later.

Directions for Mixing Oral Solution Do not add water until you dispense. When dispensing, tap bottle until all powder flows freely, slowly add the total amount of water for reconstitution (see table below). After partially filling bottle, replace cap and shake vigorously.

Add remaining water and repeat shaking. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.

125 mg/5 mL Bottle size Total Amount of Water Required for Reconstitution 100 mL 75 mL 200 mL 150 mL The resulting solution (red in color) will contain penicillin V potassium equivalent to penicillin V 125 mg (200,000 units) in each 5 mL (teaspoonful). 250 mg/5 mL Bottle size Total Amount of Water Required for Reconstitution 100 mL 75 mL 200 mL 150 mL The resulting solution (red in color) will contain penicillin V potassium equivalent to penicillin V 250 mg (400,000 units) in each 5 mL (teaspoonful).

Contraindications 11 words

CONTRAINDICATIONS A previous hypersensitivity reaction to any penicillin is a contraindication.

⚠️ Warnings ~1 min read

WARNINGS SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS.

BEFORE INITIATING THERAPY WITH PENICILLIN V POTASSIUM, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PENICILLIN V POTASSIUM SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE.

OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including penicillin V potassium tablets and penicillin V potassium for oral solution, 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 120 words

ADVERSE REACTIONS Although the incidence of reactions to oral penicillins has been reported with much less frequency than following parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been reported with oral penicillin. The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue. The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum-sicknesslike reactions, laryngeal edema, and anaphylaxis.

Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leukopenia, thrombocytopenia, neuropathy, and nephropathy are infrequent reactions and usually associated with high doses of parenteral penicillin. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Penicillin V exerts a bactericidal action against penicillin-sensitive microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci.

The drug exerts high in vitro activity against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L, and M), and pneumococci. Other organisms sensitive in vitro to penicillin V are Corynebacterium diphtheriae , Bacillus anthracis , Clostridia , Actinomyces bovis , Streptobacillus moniliformis , Listeria monocytogenes , Leptospira , and Neisseria gonorrhoeae. Treponema pallidum is extremely sensitive.

The potassium salt of penicillin V has the distinct advantage over penicillin G in resistance to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when the drug is given on an empty stomach. Average blood levels are two to five times higher than the levels following the same dose of oral penicillin G and also show much less individual variation.

Once absorbed, penicillin V is about 80% bound to serum protein. Tissue levels are highest in the kidneys, with lesser amounts in the liver, skin, and intestines. Small amounts are found in all other body tissues and the cerebrospinal fluid.

The drug is excreted as rapidly as it is absorbed in individuals with normal kidney function; however, recovery of the drug from the urine indicates that only about 25% of the dose given is absorbed. In neonates, young infants, and individuals with impaired kidney function, excretion is considerably delayed.

📦 How Supplied / Storage and Handling 213 words

HOW SUPPLIED Penicillin V Potassium Tablets, USP are available as follows: 250 mg (400,000 units): biconvex, oval, mottled, white to off-white, uncoated tablets, debossed “93” on one side and “1172” on the other side in bottles of 100 (NDC 0093-1172-01) and 1000 (NDC 0093-1172-10). 500 mg (800,000 units): biconvex, oval, mottled, white to off-white, uncoated, scored tablets, debossed “9” to the left of partial bisect and “3” to the right on one side and “1174” on the other side in bottles of 100 (NDC 0093-1174-01) and 1000 (NDC 0093-1174-10).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed. Dispense in a tight container as defined in the USP, with a child-resistant closure as required.

Penicillin V Potassium for Oral Solution, USP is available as follows: 125 mg (200,000 Units) per 5 mL: bottles of 100 mL (NDC 0093-4125-73) and 200 mL (NDC 0093-4125-74). 250 mg (400,000 Units) per 5 mL: bottles of 100 mL (NDC 0093-4127-73) and 200 mL (NDC 0093-4127-74). Keep tightly closed.

Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.

Keep this and all medications out of the reach of children.

📋 Description 219 words

DESCRIPTION Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Each Penicillin V Potassium Tablet, USP contains penicillin V potassium equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V.

The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Each Penicillin V Potassium Tablet USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each Penicillin V Potassium Tablet USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium. Penicillin V Potassium for Oral Solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V.

The inactive ingredients present are cherry flavor, FD&C Red #40, saccharin sodium, sodium benzoate, and sucrose. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium.

Monopotassium (2 S, 5 R, 6 R )-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. penicillin V potassium structural formula

💬 Information for Patients 202 words

Information for Patients Patients should be counseled that antibacterial drugs, including penicillin V potassium tablets and penicillin V potassium for oral solution, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When penicillin V potassium tablets or penicillin V potassium for oral solution 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 penicillin V potassium tablets, penicillin V potassium for oral solution, or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

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