HomeNDC LookupIngredientsAmpicillin Sodium › 55150-0114-20
Ampicillin 2 g Injection, Powder, For Solution, 10 vials — NDC 55150-0114-20 package photo

Ampicillin 2 g Injection, Powder, For Solution, 10 vials

by Eugia US LLC · 10 VIAL in 1 BOX (55150-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
NDC 55150-0114-20
🏷️ FDA NDC (as labeled) 55150-114-20 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1009-2022

🆔 Identity & classification

FDA NDC (as labeled) 55150-114-20
Product NDC 55150-114
11-digit billing NDC 55150011420
NCPDP billing unit EA — each (per item)
UNII JFN36L5S8K
UPC 0355150113101, 0355150111107, 0355150114207, 0355150112104
Application # ANDA065499
SPL Set ID b7bf2897-8272-4c7d-84e9-6fbba0ea63fa
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 2012-02-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance AMPICILLIN SODIUM
GPI-14 01200020302125
GPI class Ampicillin Sodium
GCN Seq No 008935
GCN 39243
HICL code 003952
Ingredient (HICL) Ampicillin Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.08
AHFS class Aminopenicillin Antibiotics
FDB label name AMPICILLIN 2 GM VIAL
FDB brand name Ampicillin Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 55150-114-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55150-0114-20. 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

LabelerEugia US LLC
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA065499 (ANDA)
Labeler code55150
First marketedFeb 2012
Product typeHuman Prescription Drug
Portfolio241 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 2 GM VIAL Ingredient Ampicillin Sodium
📖 What it is MedlinePlus · NLM

Ampicillin injection 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 lung, blood, heart, urinary tract, and gastrointestinal tract (includes the mouth, stomach, or intestines) infections. Ampicillin injection is in a class of medications called penicillins. It works by killing bacteria. Antibiotics such as ampicillin 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 t...

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
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $9.35
Medicare drug plans payPart D · Q2 2026 $4.43
Medicare Part B allowsASP · J0290 $0.614 / J0290 unit
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)55150-114-20
11-digit billing NDC55150-0114-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0290
DescriptorInjection, ampicillin sodium, 500 mg
Billing units / pkg40 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ampicillin 2 g 00404-9818-99 Henry 1 vial AP FDA listed
Ampicillin 2 g 00781-3408-95 Sandoz 10 vials AP FDA listed
Ampicillin 2 g 00781-3413-92 Sandoz 10 vials FDA listed
Ampicillin 2 g 00781-9273-95 Sandoz 10 vials AP FDA listed
Ampicillin 2 g 00781-9408-95 Sandoz 10 vials AP FDA listed
Ampicillin 2 g 00781-9413-92 Sandoz 10 vials FDA listed
Ampicillin 2 g/2g 23155-0917-41 Heritage 10 vials AP FDA listed
ampicillin 2 g 25021-0137-20 Sagent 10 vials AP FDA listed
Ampicillin 2 g 44567-0103-10 WG 10 vials AP FDA listed
Ampicillin 2 g 51662-1560-03 HF 10 pouches AP FDA listed
Ampicillin 2 gthis 55150-0114-20 Eugia 10 vials AP FDA listed
Ampicillin 2 g 65219-0020-23 Fresenius 10 vials AP FDA listed
Ampicillin 2 g 71872-7139-01 Medical 1 vial AP FDA listed
Ampicillin 2 g 71872-7240-01 Medical 1 vial AP FDA listed
Ampicillin sodium 2 g 71872-7342-01 Medical 1 vial AP FDA listed
Ampicillin sodium 2 g 72485-0422-10 Armas 10 vials AP FDA listed
Ampicillin 2 g 72572-0017-10 Civica, 10 vials AP FDA listed
Ampicillin sodium 2 g 72572-0094-10 Civica, 10 vials AP FDA listed
Ampicillin 2 g 72603-0454-10 NorthStar 10 vials AP FDA listed
Ampicillin 2 g 83270-0314-10 ONESOURCE 10 vials AP 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

🏛️
2012
On the market since
Feb 2012
📍
2026
Currently FDA-listed
14 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 55150-0114-20, 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
1.7K
Units reimbursed last 4 qtrs
16.7K
Gross reimbursed last 4 qtrs
$155.9K
Avg / prescription
$93.89
Avg / unit
$9.3489
Latest quarter Q4 2025
333Rx
Fee-for-service vs managed care
21% FFS 79% MCO
Fee-for-service · 352 Rx Managed care · 1,308 Rx
State Medicaid map
Alaska: no data reported AK Maine: 35 units · 2.5 per 100k residents ME Washington: no data reported WA Idaho: 30 units · 1.5 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,207 units · 6.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 519 units · 16.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 18 units · 0.6 per 100k residents IA Illinois: 265 units · 2.1 per 100k residents IL Indiana: no data reported IN Ohio: 1,232 units · 10.5 per 100k residents OH Pennsylvania: 1,661 units · 12.8 per 100k residents PA New Jersey: 1,766 units · 19.0 per 100k residents NJ Massachusetts: 148 units · 2.1 per 100k residents MA California: 220 units · 0.6 per 100k residents CA Utah: no data reported UT Colorado: 150 units · 2.6 per 100k residents CO Nebraska: no data reported NE Missouri: 231 units · 3.7 per 100k residents MO Kentucky: 52 units · 1.1 per 100k residents KY West Virginia: no data reported WV Virginia: 194 units · 2.2 per 100k residents VA Maryland: 330 units · 5.3 per 100k residents MD Connecticut: 902 units · 24.9 per 100k residents CT Rhode Island: no data reported RI Arizona: 174 units · 2.3 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 5,782 units · 81.1 per 100k residents TN North Carolina: 137 units · 1.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 240 units · 8.2 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 468 units · 1.5 per 100k residents TX Florida: 912 units · 4.0 per 100k residents FL
Units reimbursed · per 100k residents
0.681.1
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 Tennessee 81.1 /100k
2 Connecticut 24.9 /100k
3 New Jersey 19.0 /100k
4 Nevada 16.2 /100k
5 Pennsylvania 12.8 /100k
6 Ohio 10.5 /100k
7 Mississippi 8.2 /100k
8 New York 6.2 /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.

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

Medicare Part D (outpatient prescription) spending for Ampicillin Sodium (matched by generic name) — the program that covers self-administered drugs. 12 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 Ampicillin Sodium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.03M
Claims incl. refills
6K
Beneficiaries
1.1K
Spend / beneficiary
$908.40
Spend / claim
$172.93
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 Ampicillin (this brand).

Top reported reactions

Foetal Exposure During Pregnancy657
Drug Hypersensitivity606
Premature Baby512
Pyrexia375
Premature Delivery337
Acute Kidney Injury330
Renal Failure317

Age at onset

Neonate570
Infant110
Child39
Adolescent17
Adult530
Elderly223

Reporter sex

8,244 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization3,456
Death1,308
Life-threatening901
Disabling166
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 671 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 Marketing startStatus
55150-0114-20 You're viewing this 10 VIAL in 1 BOX (55150-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2012-02-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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.
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 55150-114-20, 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: 55150-0114-20, written without dashes as 55150011420. 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 55150-0114-20, the first segment (55150) is the labeler code FDA assigned to Eugia US LLC; the middle segment (0114) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eugia US LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eugia US LLC 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0290 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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 ~1 min read

INDICATIONS AND USAGE Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae, S taphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic streptococci . Bacterial Meningitis caused by E. coli , Group B Streptococci , and other Gram-negative bacteria ( Listeria m onocytogenes , N. meningitidis ). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.

Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci , and enterococci . Gram-negative sepsis caused by E. coli , Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy.

The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis . Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp.

(dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.

It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection 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. Indicated surgical procedures should be performed.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Infections of the respiratory tract and soft tissues. Patients weighing 40 kg (88 lbs) or more: 250 mg to 500 mg every 6 hours. Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females). Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours. Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.

In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections.

In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Urethritis in males due to N. gonorrhoeae .

Adults - Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required. In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended.

Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route.

A change to oral ampicillin may be made when appropriate. Bacterial Meningitis Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.

Neonates (less than or equal to 28 days of postnatal age) – Dosage should be based on Gestational age and Postnatal age according to Table 1 . Table 1: Dosage in Neonates (less than or equal to 28 days of postnatal age) for Bacterial Meningitis and Septicemia Gestational age (weeks) Postnatal age (days) Dosage lessthan or equal to 34 lessthan or equal to 7 100 mg/kg/day in equally divideddoses every 12 hours lessthan or equal to 34 greater than or equal to 8 andlessthan 28 150 mg/kg/day in equally divideddoses every 12 hours greater than 34 lessthan or equal to 28 150 mg/kg/day in equally divideddoses every 8 hours Septicemia Adults and children - 150 to 200 mg/kg/day.

Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours. Neonates (less than or equal to 28 days of postnatal age) – Dosage should be based on Gestational age and Postnatal age according to Table 1 (above). Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

A minimum of 10 days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis. DIRECTIONS FOR USE Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Intramuscular Use – Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table below: NDC Label Claim Recommended Amount of Diluent Withdrawa…

Contraindications 16 words

CONTRAINDICATIONS A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

⚠️ Warnings ~1 min read

WARNINGS Serious and occasionally fatal hypersensitivity (anaphylactoid) 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 apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.

SERIOUS ANAPHYLACTOID 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 ampicillin for injection, 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 ~1 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 penicillins 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: Gastrointestinal Glossitis, stomatitis, black “hairy” tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea.

(These reactions are usually associated with oral dosage forms.) Hypersensitivity Reactions Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Linear IgA bullous dermatosis has been reported.

Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form. Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with 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 the immediate use of epinephrine, oxygen, and intravenous steroids. Liver – A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is unknown. Mild transitory SGOT elevations have been observed in individuals receiving larger (two to four times) than usual and oft-repeated intramuscular injections.

Evidence indicates that glutamic oxaloacetic transaminase (GOT) is released at the site of intramuscular injection of ampicillin sodium and that the presence of increased amounts of this enzyme in the blood does not necessarily indicate liver involvement. Hemic and Lymphatic Systems – Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System - Seizures

🔄 Drug Interactions 49 words

Drug Interactions The concurrent administration of allopurinol and ampicillin increases substantially the 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.

🔄 Drug / Laboratory Test Interactions 43 words

Drug/Laboratory Test Interactions With high urine concentrations of ampicillin, false-positive glucose reactions may occur if Clinitest, Benedict’s Solution, or Fehling’s Solution are used. Therefore, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Tes-Tape) be used.

🤰 Pregnancy 60 words

Pregnancy Reproduction studies have been performed in laboratory animals at doses several times the human dose and have revealed no evidence of adverse effects due to ampicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 20 words

Pediatric Use Guidelines for the administration of these drugs to children, including neonates are presented in DOSAGE AND ADMINISTRATION section.

🆘 Overdosage 32 words

OVERDOSAGE In cases of overdose, 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 peritoneal dialysis.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Ampicillin for injection diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. Ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid.

Due to maturational changes in renal function, ampicillin half-life decreases as postmenstrual age (a sum of gestational age and postnatal age) increases for infants with postnatal age of less than 28 days. The active form appears in the bile in higher concentrations than those found in serum. Ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins.

Ampicillin for injection is well-tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions. Microbiology While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been demonstrated. Antibacterial Activity The following bacteria have been shown in in vitro studies to be susceptible to ampicillin for injection: Gram-positive Bacteria Hemolytic and nonhemolytic streptococci Streptococcus pneumoniae Nonpenicillinase-producing staphylococci Clostridium spp.

B. anthracis Listeria monocytogenes Most strains of enterococci. Gram-negative Bacteria H. influenzae N. gonorrhoeae N. meningitidis Proteus mirabilis Many strains of Salmonella , Shigella , and E. coli . AMPICILLIN does not resist destruction by penicillinase.

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.

📦 How Supplied / Storage and Handling 188 words

HOW SUPPLIED Ampicillin for injection, USP for intramuscular or intravenous injection. It is a white to off-white crystalline powder supplied in vials containing ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin per vial. The following packages are available: NDC Vial Package Factor 55150-111-10 Ampicillin for injection USP, 250 mg in 10 mL vial Box of 10 vials 55150-112-10 Ampicillin for injection USP, 500 mg in 10 mL vial Box of 10 vials 55150-113-10 Ampicillin for injection USP, 1 g in 15 mL vial Box of 10 vials 55150-114-20 Ampicillin for injection USP, 2 g in 24 mL vial Box of 10 vials Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect the constituted solution from freezing. The vial stopper is not made with natural rubber latex. Clinitest is a registered trademark of Miles, Inc.

Clinistix is a registered trademark of Bayer Corporation. Tes-Tape is a registered trademark of Eli Lilly Company. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd.

E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India Revised: January 2024

📋 Description 160 words

DESCRIPTION Ampicillin for injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for injection, USP is a white to off-white crystalline powder.

The reconstituted solution is clear, colorless and free from visible particulates. Each vial of ampicillin for injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP contains sodium content as 16.46 mg (0.72 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g or 131.66 mg (5.72 mEq) per 2 g of ampicillin.

It has the following molecular structure: The molecular formula is C 16 H 18 N 3 NaO 4 S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10. Chemical Structure

💬 Information for Patients 173 words

Information for Patients 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. 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.