HomeNDC LookupIngredientsAmpicillin › 70518-2607-00
Ampicillin 500 mg Capsule, 28-count — NDC 70518-2607-00 package photo

Ampicillin 500 mg Capsule, 28-count

by REMEDYREPACK INC. · 28 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-0)
NDC 70518-2607-00
🏷️ FDA NDC (as labeled) 70518-2607-0 billing pads the package segment with a zero
This package
Contains28-count Pack sizes2 compare ↓
Also comes in: 28 capsules 70518-2607-01
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70518-2607-0
Product NDC 70518-2607
11-digit billing NDC 70518260700
NCPDP billing unit EA — each (per item)
RxCUI 308212
UNII HXQ6A1N7R6
Application # ANDA064082
SPL Set ID 4134cd79-c895-4e6e-b1d5-8e01c38bf2d1
Established class (EPC) Penicillin-class Antibacterial
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2020-02-28
Route ORAL
Dosage form CAPSULE
Substance AMPICILLIN TRIHYDRATE
GCN Seq No 008942
GCN 39272
HICL code 003953
Ingredient (HICL) Ampicillin Trihydrate
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 08:12.16.08
AHFS class Aminopenicillin Antibiotics
FDB label name AMPICILLIN 500 MG CAPSULE
FDB brand name Ampicillin Trihydrate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-2607-0 — 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 → 70518-2607-00. 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) Penicillins with extended spectrum, Antibiotics
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

LabelerREMEDYREPACK INC.
Application holderSANDOZ INC
FDA applicationANDA064082 (ANDA)
Labeler code70518
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio1,511 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 AMPICILLIN 500 MG CAPSULE Ingredient Ampicillin Trihydrate
📖 What it is MedlinePlus · NLM

Ampicillin is used to treat certain infections that are caused by bacteria such as meningitis (infection of the thin layers that cover and protect the brain and spinal cord); and infections of the throat, sinuses, lungs, reproductive organs, urinary tract, and gastrointestinal tract (includes the mouth, stomach, or intestines). Ampicillin is in a class of medications called penicillins. It works by killing bacteria. Antibiotics such as ampicillin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection late...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Ampicillin treats a range of bacterial infections — things like respiratory infections, urinary tract infections, stomach and intestinal infections including typhoid fever, and mor...
  • What kinds of infections does ampicillin treat?
  • Follow the instructions your prescriber or pharmacist gave you specifically for your prescription. If you're unsure, check with your pharmacist — they can confirm whether your part...
  • Is it okay to take the capsules with food?
📖 Read our full Ampicillin guide →
7
Nutrient depletion considerations

Ampicillin 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
ShapeCapsule
ImprintGG851;GG851
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 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.

8 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 28 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ampicillin 500 mg 00781-2145-01 Sandoz 100 capsules $0.439 AB Availability likely
Ampicillin 500 mg 59651-0551-01 Aurobindo 100 capsules $0.439 Availability likely
Ampicillin 500 mgthis 70518-2607-00 REMEDYREPACK 28 capsules AB Discontinued
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70518-2607-00 You're viewing this 28 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-0) 2020-02-28 Discontinued by firm
70518-2607-01 28 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-1) 2025-07-17 Active

Pack size FAQ

What quantity is in NDC 70518-2607-00?
NDC 70518-2607-00 is a 28-count package — 28 capsule in 1 bottle, plastic.
What is the difference between NDC 70518-2607-00 and NDC 70518-2607-01?
Both are Ampicillin 500 mg Capsule — the drug itself is identical. NDC 70518-2607-00 is the 28-count package, while NDC 70518-2607-01 is the 28 capsules package.
What NDC number is used to bill for this package of Ampicillin 500 mg Capsule?
Bill NDC 70518-2607-00 — the 11-digit billing format is 70518260700. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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.
“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 70518-2607-0, 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: 70518-2607-00, written without dashes as 70518260700. 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 70518-2607-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (2607) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 28 capsules (70518-2607-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
REMEDYREPACK 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 202 words

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

Ampicillin capsules and ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below: Infections of the genitourinary tract including gonorrhea: E. coli, P. mirabilis, enterococci , Shigella, S. typhosa and other Salmonella , and nonpenicillinase producing N. gonorrhoeae . Infections of the respiratory tract: Nonpenicillinase- producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae . Infections of the gastrointestinal tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci .

Meningitis: N. Meningitides . Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed.

Therapy may be instituted prior to the results of susceptibility testing.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Adults and children weighing over 20 kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea.

Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis.

For respiratory tract infections , the usual dose is 250 mg qid in equally spaced doses. Pediatric patients weighing 20 kg or less: For genitourinary or gastrointestinal tract infections , the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses. For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily.

Doses for children should not exceed doses recommended for adults. All Patients, Irrespective of Age and Weight : Larger doses may be required for severe or chronic infections. Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one-half hour before or two hours after meals for maximal absorption.

Except for the single dose regimen for gonorrhea referred to above, therapy should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by hemolytic strains of streptococci, a minimum of 10 days’ treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis (see PRECAUTIONS–Laboratory Tests ). In the treatment of chronic urinary or gastrointestinal infections, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards.

Stubborn infections may require treatment for several weeks. Smaller doses than those indicated above should not be used.

Contraindications 57 words

CONTRAINDICATIONS The use of Ampicillin is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin or to other beta-lactam antibacterial drugs. Ampicillin is also contraindicated in infections caused by penicillinase-producing organisms. Ampicillin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with ampicillin.

⚠️ Warnings ~2 min read

WARNINGS SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH 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 THERAPY WITH ANY PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, APPROPRIATE THERAPY SHOULD BE CONSIDERED.

SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Severe Cutaneous Adverse Reactions Ampicillin may cause severe cutaneous adverse reactions (SCARs), such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), exfoliative dermatitis, erythema multiforme, and acute generalized exanthematous pustulosis (AGEP).

If patients develop a skin rash, they should be monitored closely, and ampicillin discontinued if lesions progress. Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of ampicillin. Hepatic toxicity is usually reversible; however, deaths have been reported.

Hepatic function should be monitored at regular intervals in patients with hepatic impairment. Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ampicillin, 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillin and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of ampicillin: Infections and Infestations: Clostridioides difficile -associated diarrhea (see WARNINGS section).

Gastrointestinal : glossitis, stomatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs. Hypersensitivity Reactions : Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, and acute generalized exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics (see WARNINGS ).

An erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash, which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days.

Other hypersensitivity reactions that have been reported are: skin rash, pruritus, urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis. Linear IgA bullous dermatosis has been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form of the drug.

NOTE : Urticaria, other skin rashes, and serum sickness-like reactions may be controlled by antihistamines, and, if necessary, systemic corticosteroids. Whenever such reactions occur, ampicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening, and amenable only to ampicillin therapy. Serious anaphylactic reactions require emergency measures (see WARNINGS ).

Liver : Moderate elevation in serum glutamic oxaloacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown. Hemic and Lymphatic Systems : Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Other adverse reactions that have been reported with the use of ampicillin are laryngeal stridor and high fever. An occasional patient may complain of sore mouth or tongue as with any oral penicillin preparation.

🔄 Drug Interactions 115 words

Drug Interactions When administered concurrently, the following drugs may interact with ampicillin. Allopurinol : Substantially increased incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Bacteriostatic Antibiotics : Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well-documented. Oral Contraceptives : May be less effective and increased breakthrough bleeding may occur.

Probenecid : May decrease renal tubular secretion of ampicillin resulting in increased blood levels and/or ampicillin toxicity.

🔄 Drug / Laboratory Test Interactions 68 words

Drug/Laboratory Test Interactions After treatment with ampicillin, a false-positive reaction for glucose in the urine may occur with copper sulfate tests (Benedict’s solution, Fehling’s solution, or Clinitest ® tablets) but not with enzyme based tests such as Clinistix ® and Tes-Tape ® . Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted.

🤰 Pregnancy 59 words

Pregnancy Teratogenic Effects Reproduction studies in animals have revealed no evidence of impaired fertility or harm to the fetus due to penicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, penicillin should be used during pregnancy only if clearly needed. (See PRECAUTIONS-Drug/Laboratory Test Interactions .)

🧒 Pediatric Use 51 words

Pediatric Use Penicillins are excreted primarily unchanged by the kidney; therefore, the incompletely developed renal function in neonates and young infants will delay the excretion of penicillin. Administration to neonates and young infants should be limited to the lowest dosage compatible with an effective therapeutic regimen (see DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 33 words

OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not by peritoneal dialysis.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Ampicillin is bactericidal at low concentrations and is clinically effective not only against the gram-positive organisms usually susceptible to penicillin G but also against a variety of gram-negative organisms. It is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tract. It diffuses readily into most body tissues and fluids; however, penetration into the cerebrospinal fluid and brain occurs only with meningeal inflammation.

Ampicillin is excreted largely unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid which inhibits the renal tubular secretion of ampicillin. In blood serum, ampicillin is the least bound of all the penicillins; an average of about 20 percent of the drug is bound to plasma proteins as compared to 60 to 90 percent of the other penicillins. The administration of 500 mg dose of ampicillin capsules results in an average peak blood serum level of approximately 3.0 mcg/mL.

Microbiology Mechanism of Action Ampicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria. Mechanism of Resistance Resistance to ampicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of ampicillin, rendering it inactive.

Antimicrobial Activity Ampicillin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section. Gram-positive Bacteria Enterococcus spp. Staphylococcus spp.

(non-penicillinase-producing) Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci Gram-negative Bacteria Escherichia coli Haemophilus influenzae (non-penicillinase-producing) Neisseria gonorrhoeae Neisseria meningitidis Proteus mirabilis Salmonella spp. Shigella spp. The following in vitro data are available, but their clinical significance is unknown.

At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to 0.12 mcg/mL for ampicillin. However the efficacy of ampicillin in treating clinical infections due to these bacteria has not been established in adequate and well-controlled trials. Gram-positive Bacteria Bacillus anthracis Corynebacterium xerosis Anaerobic Bacteria Clostridium spp.

Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

🧬 Mechanism of Action 38 words

Mechanism of Action Ampicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.

📦 How Supplied / Storage and Handling 85 words

HOW SUPPLIED Ampicillin capsules, USP: Each capsule, for oral administration, contains ampicillin trihydrate equivalent to 500 mg ampicillin, and are supplied as: 500 mg: White, opaque, hard gelatin capsules, imprinted in black ink GG 851/GG 851. NDC: 70518-2607-00 NDC: 70518-2607-01 PACKAGING: 28 in 1 BOTTLE PLASTIC PACKAGING: 28 in 1 BOTTLE PLASTIC Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 94 words

DESCRIPTION Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6- aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5 R , 6 R )-6-[( R )-2-Amino-2-phenylacetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2- carboxylic acid. Its structural formula is: Molecular formula: C 16 H 19 N 3 O 4 S · 3 H 2 O Molecular weight: 403.5 Ampicillin capsules, USP for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin.

Inactive ingredients: black iron oxide, gelatin, magnesium stearate, titanium dioxide, shellac, propylene glycol, ammonium hydroxide, and potassium hydroxide. ampicillin-chemical-structure

💬 Information for Patients ~1 min read

Information for the Patient The patient should inform the physician of any history of sensitivity to allergens, including previous hypersensitivity reactions to penicillins and cephalosporins (see WARNINGS ). Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking ampicillin immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see WARNINGS ].

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, 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 antibacterial. If this occurs, patients should contact their physician as soon as possible.

Ampicillin should be taken with a full glass (8 oz) of water, one-half hour before or two hours after meals. Diabetic patients should consult with the physician before changing diet or dosage of diabetes medication (see PRECAUTIONS–Drug/Laboratory Test Interactions ). Patients should be counseled that antibacterial drugs including ampicillin should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When ampicillin is 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 ampicillin or other antibacterial drugs in the future.

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