![PENICILLIN G POTASSIUM 5000000 [iU]/1 Injection, Powder, For Solution, 1 injection — NDC 51662-1689-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=50c7500f-be06-01af-e063-6294a90a0135&name=51662-1689-1+RFID.jpg)
PENICILLIN G POTASSIUM 5000000 [iU]/1 Injection, Powder, For Solution, 1 injection
Other active recalls for Penicillin G Potassium (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Penicillin-class Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Penicillin G injection is used to treat and prevent certain infections caused by bacteria. Penicillin G injection is in a class of medications called penicillins. It works by killing bacteria that cause infections. Antibiotics such as penicillin G injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Penicillin G injection is reserved for serious, potentially life-threatening infections where we need high levels of antibiotic in your blood fast. An IV or intramuscular injection...
- Why am I getting this antibiotic through an IV instead of just taking a pill?
- Prior exposure without a reaction is reassuring, but it doesn't completely rule out a future allergic reaction. Allergies can develop over time or after repeated exposures. The mor...
- I've taken penicillin before without a problem. Do I still need to worry about an allergic reaction?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Penicillin G Potassium — tap one for details:
Penicillin G Potassium may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
1 inactive ingredient listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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💲 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 mL | 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 · Q2 2026 | $38.82 | — |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pfizerpen 5000000 [iU] 00049-0420-10 | Roerig | 10 vials | — | AP | FDA listed | — |
| Pfizerpen 20000000 [iU] 00049-0430-20 | Roerig | 1 vial | — | AP | FDA listed | — |
| Pfizerpen 5000000 [iU] 00049-0520-22 | Roerig | 10 vials | — | AP | FDA listed | — |
| Pfizerpen 20000000 [iU] 00049-0530-22 | Roerig | 1 vial | — | AP | FDA listed | — |
| Penicillin G Potassium 5000000 [iU] 00781-6135-95 | Sandoz | 10 vials | — | — | FDA listed | — |
| Penicillin G Potassium 20000000 [iU] 00781-6136-94 | Sandoz | 1 vial | — | — | FDA listed | — |
| Penicillin G Potassium 5000000 [iU] 25021-0153-20 | Sagent | 10 vials | — | AP | FDA listed | — |
| Penicillin G Potassium 20000000 [iU] 25021-0154-51 | Sagent | 1 vial | — | AP | FDA listed | — |
| Penicillin G Potassium 1000000 [iU] 44567-0310-10 | WG | 10 vials | — | — | FDA listed | — |
| Penicillin G Potassium 5000000 [iU] 44567-0311-10 | WG | 10 vials | — | AP | FDA listed | — |
| Penicillin G Potassium 20000000 [iU] 44567-0312-10 | WG | 10 vials | — | AP | FDA listed | — |
| Buffered Penicillin G Potassium 5000000 [iU] 51662-1436-01 | HF | 1 injection | — | — | Discontinued | — |
| Penicillin G Potassium 5000000 [iU]this 51662-1689-01 | HF | 1 injection | — | AP | FDA listed | — |
| Penicillin G Potassium 20000000 [iU] 70860-0127-51 | Athenex | 1 vial | — | AP | FDA listed | — |
| Penicillin G Potassium 5000000 [iU] 72603-0210-01 | NorthStar | 1 vial | — | AP | FDA listed | — |
| Penicillin G Potassium 20000000 [iU] 72603-0345-01 | NorthStar | 1 vial | — | AP | FDA listed | — |
| Penicillin G Potassium 5000000 [iU] 83634-0102-20 | Avenacy | 10 vials | — | AP | FDA listed | — |
| Penicillin G Potassium 20000000 [iU] 83634-0103-51 | Avenacy | 1 vial | — | AP | FDA listed | — |
| Penicillin G Potassium 5000000 [iU] 51662-1709-01 | HF | 1 injection | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51662-1689-01 You're viewing this | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (51662-1689-1) | 2024-03-01 | Active |
🧭 About this NDC listing & data coverage
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 | ✓ 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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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Do I need a prescription for this product?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Therapy Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued.
To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs, Penicillin G Potassium for Injection, 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.
Table
⏱️ Dosage and Administration ▾
Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Adult Patients (*)Because of its short half-life, Penicillin G is administered in divided doses, usually every 4-6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours. Pediatric Patients This product should not be administered to patients requiring less than one million units per dose.
(see PRECAUTIONS, Pediatric Use) Renal Impairment Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows: Creatinine clearance less than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours. Uremic patients with a creatinine clearance greater than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours.
Additional dosage modifications should be made in patients with hepatic disease and renal impairment. For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Reconstitution The following table shows the amount of solvent required for solution of various concentrations: When the required volume of solvent is greater than the capacity of the vial, the penicillin can be dissolved by first injecting only a portion of the solvent into the vial, then withdrawing the resultant solution and combining it with the remainder of the solvent in a larger sterile container.
Buffered Penicillin G Potassium for Injection is highly water soluble. It may be dissolved in small amounts of Water for Injection, or Sterile Isotonic Sodium Chloride Solution for Parenteral Use. Buffered Penicillin G Potassium for Injection may be given intramuscularly or by continuous intravenous drip for dosages of 500,000, 1,000,000, or 5,000,000 units.
It is also suitable for intrapleural, intraarticular, and other local instillations. THE 20,000,000 UNITS DOSAGE MAY BE ADMINISTERED BY INTRAVENOUS INFUSION ONLY. (1) Intramuscular Injection Keep total volume of injection small.
The intramuscular route is the preferred route of administration. Solutions containing up to 100,000 units of penicillin per mL of diluent may be used with a minimum of discomfort. Greater concentration of penicillin G per mL is physically possible and may be employed where therapy demands.
When large dosages are required, it may be advisable to administer aqueous solutions of penicillin by means of continuous intravenous drip. (2) Continuous Intravenous Drip Determine the volume of fluid and rate of its administration required by the patient in a 24-hour period in the usual manner for fluid therapy, and add the appropriate daily dosage of penicillin to this fluid. For example, if an adult patient requires 2 liters of fluid in 24 hours and a daily dosage of 10 million units of penicillin, add 5 million units to 1 liter and adjust the rate of flow so the liter will be infused in 12 hours.
(3) Intrapleural or Other Local Infusion If fluid is aspirated, give infusion in a volume equal to ¼ or ½ the amount of fluid aspirated, otherwise, prepare as for intramuscular injection. (4) Intrathecal Use The intrathecal use of penicillin in meningitis must be highly individualized. It should be employed only with full consideration of the possible irritating effects of penicillin when used by this route.
The preferred route of therapy in bacterial meningitides is intravenous,…
⛔ Contraindications ▾
A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
⚠️ 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 G, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, penicillin G should be discontinued, and the 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 G Potassium for Injection, USP, 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 ▾
Body as a whole The Jarisch-Herxheimer reaction is a systemic reaction, that may occur after the initiation of penicillin therapy in patients with syphilis or other spirochetal infections (i.e., Lyme disease and Relapsing fever). The reaction begins one to two hours after initiation of therapy and disappears within 12 to 24 hours. It is characterized by fever, chills, myalgias, headache, exacerbation of cutaneous lesions, tachycardia, hyperventilation, vasodilation with flushing and mild hypotension.
The pathogenesis of the Herxheimer reaction may be due to the release from the spirochetes of heat-stable pyrogen. Hypersensitivity reactions The reported incidence of allergic reactions to all penicillins ranges from 0.7 to 10 percent in different studies (see WARNINGS). Sensitization is usually the result of previous treatment with a penicillin, but some individuals have had immediate reactions when first treated.
In such cases, it is postulated that prior exposure to penicillin may have occurred via trace amounts present in milk or 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 (see WARNINGS).
Such immediate anaphylactic reactions are very rare and usually occur after parenteral therapy, but a few cases of anaphylaxis have been reported following 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, fever and, occasionally, laryngeal edema. Delayed reactions to penicillin therapy usually occur within 1 to 2 weeks after initiation of therapy.
Manifestations include serum sickness-like symptoms, i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain and various skin rashes, ranging from maculopapular eruptions to exfoliative dermatitis. Contact dermatitis has been observed in individuals who prepare penicillin solutions. Gastrointestinal system Pseudomembranous colitis has been reported with the onset occurring during or after penicillin G treatment.
Nausea, vomiting, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral therapy. Hematologic system Reactions include neutropenia, which resolves after penicillin therapy is discontinued; Coombs-positive hemolytic anemia, an uncommon reaction, occurs in patients treated with intravenous penicillin G in doses greater than 10 million units/day and who have previously received large doses of the drug; and with large doses of penicillin, a bleeding diathesis can occur secondary to platelet dysfunction.
Metabolic Penicillin G Potassium, USP (1 million units contains 1.68 mEq of potassium ion) may cause serious and even fatal electrolyte disturbances, i.e., hyperkalemia, when given intravenously in large doses. Nervous system Neurotoxic reactions including hyperreflexia, myoclonic twitches, seizures and coma have been reported following the administration of massive intravenous doses and are more likely in patients with impaired renal function. Urogenital system Renal tubular damage and interstitial nephritis have been associated with large intravenous doses of penicillin G.
Manifestations of this reaction may include fever, rash, eosinophilia, proteinuria, eosinophiluria, hematuria and a rise in serum urea nitrogen. Discontinuation of penicillin G results in resolution in the majority of patients. Local reactions Phlebitis and thrombophlebitis may occur, and pain at the injection site has been reported with intravenous administration.
To report SUSPECTED ADVERSE REACTIONS, contact 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🆘 Overdosage ▾
Dose related toxicity may arise with the use of massive doses of intravenous penicillins (40 to 100 million units per day), particularly in patients with severe renal impairment (see PRECAUTIONS). The manifestations may include agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy. Hyperkalemia is also possible (see ADVERSE REACTIONS, Metabolic).
In case of overdosage, discontinue penicillin, treat symptomatically and institute supportive measures as required. If necessary, hemodialysis may be used to reduce blood levels of penicillin G, although the degree of effectiveness of this procedure is questionable.
🧬 Clinical Pharmacology ▾
After an intravenous infusion of penicillin G, peak serum concentrations are attained immediately after completion of the infusion. In a study of ten patients administered a single 5 million unit dose of penicillin G intravenously over 3 to 5 minutes, the mean serum concentrations were 400 mcg/mL, 273 mcg/mL and 3 mcg/mL at 5 to 6 minutes, 10 minutes and 4 hours after completion of the injection, respectively. In a separate study, five healthy adults were administered one million units of penicillin G intravenously, either as a bolus over 4 minutes or as an infusion over 60 minutes.
The mean serum concentration eight minutes after completion of the bolus was 45 mcg/mL and eight minutes after completion of the infusion was 14.4 mcg/mL. The mean β-phase serum half-life of penicillin G administered by the intravenous route in ten patients with normal renal function was 42 minutes, with a range of 31 to 50 minutes. The clearance of penicillin G in normal individuals is predominantly via the kidney.
The renal clearance, which is extremely rapid, is the result of glomerular filtration and active tubular transport, with the latter route predominating. Urinary recovery is reported to be 58 to 85% of the administered dose. Renal clearance of penicillin is delayed in premature infants, neonates and in the elderly due to decreased renal function.
The serum half-life of penicillin G correlates inversely with age and clearance of creatinine and ranges from 3.2 hours in infants 0 to 6 days of age to 1.4 hours in infants 14 days of age or older. Nonrenal clearance includes hepatic metabolism and, to a lesser extent, biliary excretion. The latter routes become more important with renal impairment.
Probenecid blocks the renal tubular secretion of penicillin. Therefore, the concurrent administration of probenecid prolongs the elimination of penicillin G and, consequently, increases the serum concentrations. Penicillin G is distributed to most areas of the body including lung, liver, kidney, muscle, bone and placenta.
In the presence of inflammation, levels of penicillin in abscesses, middle ear, pleural, peritoneal and synovial fluids are sufficient to inhibit most susceptible bacteria. Penetration into the eye, brain, cerebrospinal fluid (CSF) or prostate is poor in the absence of inflammation. With inflamed meninges, the penetration of penicillin G into the CSF improves, such that the CSF/serum ratio is 2 to 6%.
Inflammation also enhances its penetration into the pericardial fluid. Penicillin G is actively secreted into the bile resulting in levels at least 10 times those achieved simultaneously in serum. Penicillin G penetrates poorly into human polymorphonuclear leukocytes.
In the presence of impaired renal function, the β-phase serum half-life of penicillin G is prolonged. β-phase serum half-lives of one to two hours were observed in azotemic patients with serum creatinine concentrations <3 mg/100 mL and ranged as high as 20 hours in anuric patients. A linear relationship, including the lowest range of renal function, is found between the serum elimination rate constant and renal function as measured by creatinine clearance. In patients with altered renal function, the presence of hepatic insufficiency further alters the elimination of penicillin G.
In one study, the serum half-lives in two anuric patients (excreting <400 mL urine/day) were 7.2 and 10.1 hours. A totally anuric patient with terminal hepatic cirrhosis had a penicillin half-life of 30.5 hours, while another patient with anuria and liver disease had a serum half-life of 16.4 hours. The dosage of penicillin G should be reduced in patients with severe renal impairment, with additional modifications when hepatic disease accompanies the renal impairment.
Hemodialysis has been shown to reduce penicillin G serum levels. Microbiology Penicillin G is bactericidal against penicillin-susceptible microorganisms during the stage of active multiplication. It acts by inhibiting biosynthesis…
📦 How Supplied / Storage and Handling ▾
NDC 51662-1689-1 5,000,000 units per vial 1 Vial per carton Storage Conditions Store dry powder at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Sterile constituted solutions may be kept in a refrigerator at 2o to 8oC (36o to 46oF). When refrigerated, penicillin solutions may be stored for seven days without loss of potency.
DISCARD UNUSED SOLUTION AFTER 7 DAYS. Sterile, Nonpyrogenic, Preservative-free. This container closure is not made with natural rubber latex.
Distributed by: HF Acquisition Co LLC dba HealthFirst
📋 Description ▾
Penicillin G Potassium, USP is a natural penicillin. It is chemically designated 4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylicacid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino], monopotassium salt, [2S-(2α, 5α, 6β)]. Penicillin G potassium is a colorless or white crystal, or a white crystalline powder which is odorless, or practically so, and moderately hygroscopic.
It is freely soluble in water, in isotonic sodium chloride solution and in dextrose solution. The structural formula is as shown below. Buffered Penicillin G Potassium for Injection is a sterile, pyrogen-free powder for reconstitution.
Buffered Penicillin G Potassium for Injection is an antibacterial agent for intramuscular, continuous intravenous drip, intrapleural or other local infusion, and intrathecal administration. Penicillin G Potassium for Injection, USP is supplied in vials equivalent to 5,000,000 units (5 million units) or 20,000,000 units (20 million units) of penicillin G as the potassium salt. Each million units contains approximately 6.8 milligrams of sodium (0.3 mEq) and 65.6 milligrams of potassium (1.68 mEq).
Buffered with sodium citrate to a pH of 6.0 to 8.5. structure