Home › NDC Lookup › Ingredients › Ceftriaxone Sodium › 66288-6100-01

💉image loading
(from DailyMed)

Ceftriaxone 100 g Injection, Powder, For Solution, 1 injection

by Samson Medical Technologies, LLC · 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-6100-1)

NDC 66288-6100-01

🏷️ FDA NDC (as labeled) 66288-6100-1 billing pads the package segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 66288-6100-1

Product NDC 66288-6100

11-digit billing NDC 66288610001

NCPDP billing unit EA — each (per item)

RxCUI 309090

UNII 023Z5BR09K

Application # ANDA090057

SPL Set ID 5cd2d96f-83e5-4326-ae87-d0ede4ba493a

Established class (EPC) Cephalosporin Antibacterial

Chemical class Cephalosporins

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2014-06-30

Route INTRAVENOUS

Dosage form INJECTION, POWDER, FOR SOLUTION

Substance CEFTRIAXONE SODIUM

GPI-14 02300090102180

GPI class cefTRIAXone Sodium

GCN Seq No 059848

GCN 25754

HICL code 003996

Ingredient (HICL) Ceftriaxone Sodium

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W1

Therapeutic class — intermediate (HIC2) Antibiotics

HIC3 code W1Y

Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 3Rd Generation

AHFS code 08:12.06.12

AHFS class 3Rd Generation Cephalosporin Antibiotics

FDB label name CEFTRIAXONE 100 GRAM BULK BAG

FDB brand name Ceftriaxone

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 66288-6100-1 — 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 → 66288-6100-01. 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 Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial

Drug family (ATC) Third-generation cephalosporins

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

LabelerSamson Medical Technologies, LLC

Application holderSAMSON MEDICAL TECHNOLOGIES LLC

FDA applicationANDA090057 (ANDA)

Labeler code66288

First marketedJun 2014

Product typeHuman Prescription Drug

🔎 All NDCs from Samson Medical Technologies, LLC

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 CEFTRIAXONE 100 GRAM BULK BAG Ingredient Ceftriaxone Sodium

📖 What it is MedlinePlus · NLM

Ceftriaxone injection is used to treat certain infections caused by bacteria. Ceftriaxone injection is also given before certain types of surgery to prevent infections that may develop after an operation. Ceftriaxone injection is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as ceftriaxone injection will not work for colds, flu, or other viral infections.Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Ceftriaxone is only available as an injection — there's no pill form. The good news is that it works fast and reaches very high levels throughout the body, including areas that are...
Why am I getting an injection instead of a pill?
It depends on the type of infection. Some infections — like uncomplicated gonorrhea or an ear infection in a child — are treated with just a single dose. For more serious infection...
How long will I need to take ceftriaxone?

📖 Read our full Ceftriaxone Injection guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion +2 more

🧪 Full Ceftriaxone nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 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	$27.41	—

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ceftriaxone 10 g 00143-9678-01	Hikma	1 injection	—	AP	FDA listed	—
Ceftriaxone Sodium 10 g/100mL 00409-7334-10	Hospira,	1 vial	—	AP	FDA listed	—
Ceftriaxone Sodium 10 g/100mL 00781-3210-46	Sandoz	1 vial	—	AP	FDA listed	—
Ceftriaxone 10 g 44567-0703-01	WG	1 vial	—	AP	FDA listed	—
Ceftriaxone Sodium 10 g 60505-6150-05	Apotex	1 vial	—	AP	FDA listed	—
Ceftriaxone 100 gthis 66288-6100-01	Samson	1 injection	—	—	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

🏛️

2014

On the market since

Jun 2014

📍

2026

Currently FDA-listed

12 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.

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

Medicare Part D (outpatient prescription) spending for Ceftriaxone — the program that covers self-administered drugs. 9 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 Ceftriaxone. 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

$4.52M

Claims incl. refills

89.6K

Beneficiaries

47K

Spend / beneficiary

$96.18

Spend / claim

$50.45

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
66288-6100-01 You're viewing this	1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-6100-1)	2014-06-30	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	— Not published for this NDC No photo available yet for this listing.
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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

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 66288-6100-1, 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: 66288-6100-01, written without dashes as 66288610001. 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 66288-6100-01, the first segment (66288) is the labeler code FDA assigned to Samson Medical Technologies, LLC; the middle segment (6100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Samson Medical Technologies, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Samson Medical Technologies, 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.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and other antibacterial drugs, Ceftriaxone 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.

Ceftriaxone for Injection is indicated for the treatment of the following infections when caused by susceptible bacteria: Ceftriaxone for Injection, USP is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria: Lower Respiratory Tract Infections ( 1.1 ); Skin and Skin Structure Infections ( 1.2 ); Complicated and Uncomplicated Urinary Tract Infections ( 1.3 ); Pelvic Inflammatory Disease ( 1.4 ); Bacterial Septicemia ( 1.5 ); Bone and Joint infections ( 1.6 ); Intra-abdominal Infections ( 1.7 ); Meningitis ( 1.8 ); and Surgical Prophylaxis ( 1.9 ).

1.1Lower Respiratory Tract Infections Lower respiratory tract infections caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens .

1.2Skin and Skin Structure Infections Skin and skin structure infections caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii The efficacy for these organisms in this organ system were studied in fewer than ten infections. , Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis or Peptostreptococcus species.

1.3Complicated and Uncomplicated Urinary Tract Infections Complicated and uncomplicated urinary tract infections caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae .

1.4Pelvic Inflammatory Disease Pelvic inflammatory disease caused by Neisseria gonorrhoeae . Ceftriaxone sodium, like other cephalosporins, has no activity against Chlamydia trachomatis . Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

1.5Bacterial Septicemia Bacterial septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae .

1.6Bone and Joint Infections Bone and joint infections caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species.

1.7Intra-abdominal Infections Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species or Peptostreptococcus species.

1.8Meningitis Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae . Ceftriaxone sodium has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and Escherichia coli ; however, the efficacy for these organisms in this organ system were studied in fewer than ten infections.

1.9Surgical Prophylaxis The preoperative administration of a single 1 gram dose of ceftriaxone may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients,…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof. Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than the 1 gram dose of Ceftriaxone. THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION WITH STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION USE THIS FORMULATION OF CEFTRIAXONE ONLY IN PATIENTS WHO REQUIRE A 1 GRAM DOSE. For intravenous use only over approximately 30 minutes. ( 2 ) THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION.

Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof. Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than the 1 gram dose of ceftriaxone ( 2.1 ). Recommended Dosing Schedule for Ceftriaxone for Injection, USP Site and Type of Infection Dose Frequency Total Daily Dose Usual Adult Dose 1 to 2 grams Once a day or in equally divided doses every 12 hours Should not exceed 4 grams Patients with hepatic impairment and significant renal impairment should not receive more than 2 grams per day of ceftriaxone.

Surgical prophylaxis 1 gram I.V. once ½ to 2 hours before surgery Meningitis 100 mg per kg Once a day or in equally divided doses every 12 hours Should not exceed 4 grams Skin and Skin Structure Infections 50 mg per kg to 75 mg per kg Once a day or in equally divided doses every 12 hours Should not exceed 2 grams Serious Infections other than Meningitis 50 mg per kg to 75 mg per kg Every 12 hours Should not exceed 2 grams Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than the 1 gram dose of ceftriaxone. ( 2.1 )

2.1Adult Population Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof. Ceftriaxone for Injection USP Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than the 1 gram dose of Ceftriaxone. Ceftriaxone for Injection should be reconstituted with Sterile Water for Injection, USP to a concentration of 100 mg per mL and further diluted in 50 mL of a compatible solution.

The recommended adult dosages are outlined in Table 1. Ceftriaxone for Injection, USP, Pharmacy Bulk Package SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof. Ceftriaxone should be administered intravenously (I.V.) over approximately 30 minutes.

The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes , therapy should be continued for at least 10 days. Table 1: Recommended Dosing Schedule for Ceftriaxone for Injection, USP Site and Type of Infection Dose Frequency Total Daily Dose Usual Adult Dose 1 gram to 2 grams Once a day or in equally divided doses every 12 hours Should not exceed 4 grams* Surgical prophylaxis 1 gram I.V. once ½ to 2 hours before surgery Skin and Skin Structure Infections 50 to 75 mg per kg Once a day or in equally divided doses every 12 hours Should not exceed 2 grams Meningitis 100 mg per kg Once a day or in equally divided doses every 12 hours Should not exceed 4 grams* Serious Infections other than Meningitis 50 to 75 mg per kg Every 12 hours Should not exceed 2 grams *Patients with hepatic impairment and significant renal impairment should not receive more than 2 grams per day of ceftriaxone. *…

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS 100 grams Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag, SmartPak ® THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION Pharmacy Bulk Package bags, 100 grams ( 3 ) THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION

⛔ Contraindications 66 words ▾

4 CONTRAINDICATIONS Anaphylaxis to ceftriaxone or other cephalosporin class antibacterials, penicillins or other beta-lactam antibacterials ( 4.1 )

4.1Anaphylaxis to Ceftriaxone or the Cephalosporin Class of Antibacterials, Penicillins or Other Beta-Lactam Antibacterials Ceftriaxone for Injection, USP is contraindicated in patients who have a history of anaphylaxis to ceftriaxone or the cephalosporin class of antibacterials, penicillins, or other beta-lactam antibacterials [see Warnings and Precautions (5.1) ].

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Include anaphylaxis and serious skin reactions. Cross hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug ( 5.1 ).

Interaction with Calcium-containing products: Precipitation can occur. Do not administer simultaneously with calcium-containing I.V. solutions ( 5.2 ). Neurological adverse reactions: Serioous neurological adverse reactions have been reported during postmarketing surveillance.

If serious adverse reactions occur, discontinue the drug and institute appropriate supportive measures. ( 5.3 ) Clostridium difficile -associated diarrhea: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs ( 5.4 ).

Hemolytic Anemia: Severe cases of hemolytic anemia, including fatalities in adults and children, have been reported. If anemia is diagnosed, discontinue the drug until the etiology is determined. ( 5.5 )

5.1Hypersensitivity Reactions to Ceftriaxone, Cephalosporins, Penicillins or Other Drugs Serious, occasionally fatal, hypersensitivity (anaphylactic) reactions have been reported with ceftriaxone. Before therapy with Ceftriaxone for Injection, USP is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to ceftriaxone, cephalosporins, penicillins, or other drugs. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterials has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.

If an allergic reaction to Ceftriaxone for Injection, USP occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, corticosteroids, intravenous fluids, intravenous antihistamines, pressor amines, and airway management, as clinically indicated.

5.2Interaction with Calcium-Containing Products Precipitation of ceftriaxone-calcium can occur when Ceftriaxone for Injection, USP is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone for Injection must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions, such as parenteral nutrition via a Y-site. However, in patients other than neonates, Ceftriaxone for Injection, USP and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with 0.9% Sodium Chloride Injection or D5W.

In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium. [see Drug Interactions ( 7.2 ) ]

5.3Neurological Adverse Reactions Serious neurological adverse reactions have been reported during postmarketing surveillance with ceftriaxone use. These reactions include encephalopathy (disturbances of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and non-convulsive status epilepticus [see Adverse Reactions ( 6.2 ) ]. Some cases occurred in patients with severe renal impairment who did not receive appropriate dosage adjustment.

However, in other cases, neurological adverse reactions occurred in patients receiving an appropriate dosage adjustment. The neurological adverse reactions were reversible and resolved after discontinuation. If neurological adverse reactions associate with Ceftriaxone for Injection therapy occur, discontinue Ceftriaxone for Injection and institute appropriate supportive measures.

Make appropriate dosage adjustments in patients with severe renal impairment. [see Dosage and Administration ( 2.1 ) ]. 5.4 Clostridium difficile- associated Diahrrhea Clostridium difficile -associated diarrhea (CDAD) has been reported…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions to ceftriaxone are described below and elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1) ] Ceftriaxone-calcium precipitates [see Warnings and Precautions (5.2) and Drug Interactions (7.2) ] Clostridium difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Hemolytic anemia [see Warnings and Precautions (5.4) ] The most common adverse reactions occurring in >2% of patients receiving ceftriaxone include diarrhea, eosinophilia, thrombocytosis, leukopenia, and elevations of SGOT and SGPT.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Samson Medical Technologies, L.L.C. at 1-877-418-3600 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following reactions occurred in ≤ 6% of the patients: Local reactions – pain, induration, tenderness, and phlebitis after intravenous administration. Hypersensitivity – rash, pruritus, fever or chills.

Hematologic – eosinophilia, thrombocytosis, leukopenia, anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia, and prolongation of the prothrombin time. Gastrointestinal – diarrhea, nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.4 ) ].

Hepatic – elevations of SGOT, SGPT, alkaline phosphatase, bilirubin. Renal – elevations of the BUN, creatinine, and the presence of casts in the urine. Central Nervous System – headache or dizziness.

Genitourinary – moniliasis or vaginitis. Miscellaneous – diaphoresis and flushing. Ceftriaxone-calcium precipitates – Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described.

In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 ) ]. Other observed adverse reactions - abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness. inner bag

6.2Postmarketing Experience The following adverse reactions have been reported during postapproval use of ceftriaxone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to readily estimate their frequency or establish a causal relationship to drug exposure. Neurologic-Encephalopathy, seizures, myoclonus, and non-convulsive status epilepti us [see Warnings and Precautions ( 5.3 )] Gastrointestinal – stomatitis and glossitis Genitourinary – oliguria Dermatologic – exanthema, allergic dermatitis, urticaria, edema Cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported.

Anaphylaxis (including anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis and thrombocytopenia) has been reported.

6.3Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with ceftriaxone, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterials: Adverse Reactions: Allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction inclu…

🔄 Drug Interactions 98 words ▾

7 DRUG INTERACTIONS Vancomycin, amsacrine, aminoglycosides and fluconazole are physically incompatible. ( 7.1 ) Calcium-containing products: precipitation can occur. ( 7.2 )

7.1Vancomycin, Amsacrine, Aminoglycosides, and Fluconazole Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures [see Dosage and Administration (2.3) ].

7.2Calcium-containing Products Precipitation of ceftriaxone-calcium can occur when Ceftriaxone for Injection is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone for Injection, USP must not be administered simultaneously with calcium-containing intravenous solutions. Ceftriaxone for Injection and calcium-containing solutions can be administered sequentially [see Warnings and Precautions (5.2) ]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Patients with both hepatic and renal impairment should not receive more than 2 grams of ceftriaxone per day. ( 5.7 ) Renal Impairment: This formulation of Ceftriaxone for Injection USP – Pharmacy Bulk Package bag, SmartPak ® should not be used in renally impaired patients who require less than the 1 gram dose of ceftriaxone. Patients with both hepatic and renal impairment should not receive more than 2 grams of ceftriaxone per day.

( 5.7 ) Pediatric Patients: This formulation of Ceftriaxone for Injection USP – Pharmacy Bulk Package bag, SmartPak ® should not be used in pediatric patients who require less than the 1 gram adult dose of ceftriaxone. ( 2.2 , 8.4 )

8.1Pregnancy Pregnancy Category B. Reproductive studies have been performed in mice, rats, and primates at intravenous doses of 625, 586, and 84 mg/kg/day, respectively without evidence of embryotoxicity, fetotoxicity, or teratogenicity. These doses are approximately 1.5, 2.8, and 0.8 times the recommended clinical dose of 2 grams/day based on body surface area comparisons.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ceftriaxone was tested in a Segment III (pre-postnatal) study in rats at intravenous doses of up to 586 mg/kg/day approximately 2.8 times (mg/m 2 comparison) the recommended daily dose of 2 grams/day.

No adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior, and reproductive ability of the offspring.

8.3Nursing Mothers Ceftriaxone is excreted in human breast milk. Caution should be exercised when Ceftriaxone for Injection is administered to a nursing woman.

8.4Pediatric Use Ceftriaxone for Injection USP, Pharmacy Bulk Package bag, SmartPak ® should not be used in pediatric patients who require less than the 1 gram dose of ceftriaxone. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the adult 1 gram dose of ceftriaxone.

8.5Geriatric Use Of the total number of subjects in clinical studies of ceftriaxone sodium, 32% were 60 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Ceftriaxone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. The pharmacokinetics of ceftriaxone were only minimally altered in geriatric patients compared to healthy adult subjects, and dosage adjustments are not necessary for geriatric patients with ceftriaxone dosages up to 2 grams per day [see Clinical Pharmacology (12) ].

🤰 Pregnancy 143 words ▾

No adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior, and reproductive ability of the offspring.

🧒 Pediatric Use 54 words ▾

🧓 Geriatric Use 157 words ▾

🆘 Overdosage 84 words ▾

10 OVERDOSAGE Ceftriaxone overdosage has been reported in patients with severe renal impairment. Reactions have included neurological outcomes, including encephalopathy, seizures, myoclonus, and non -convulsive status epilepticus. In the event of overdosage discontinue Ceftriaxone for Injection therapy and provide general supportive treatment [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.3 ) ].

In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ceftriaxone is an antibacterial drug. [see Microbiology (12.4) ]

12.3Pharmacokinetics Average plasma concentrations of ceftriaxone following a single 30-minute intravenous (I.V.) infusion of a 0.5, 1 or 2 g dose in healthy subjects are presented in Table 3. Multiple intravenous doses ranging from 0.5 to 2 g at 12- to 24-hour intervals resulted in 15% to 36% accumulation of ceftriaxone above single dose values. TABLE 3: Ceftriaxone Plasma Concentrations After Single Dose Administration Dose/Route Average Plasma Concentrations (mcg/mL) 0.5 hr 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 16 hr 24 hr 0.5 gram I.V.

I.V. doses were infused at a constant rate over 30 minutes. 82 59 48 37 29 23 15 10 5 1 gram I.V. 151 111 88 67 53 43 28 18 9 2 grams I.V.

257 192 154 117 89 74 46 31 15 Over a 0.15 to 3 g dose range in healthy adult subjects, the mean elimination half-life ranged from 5.8 to 8.7 hours, plasma clearance ranged from 0.58 to

1.45L/hour, and renal clearance ranged from 0.32 to

0.73L/hour. Distribution Ceftriaxone is reversibly bound to human plasma proteins and the binding of ceftriaxone decreases with increasing concentration from a value of 95% at plasma concentrations less than 25 mcg/mL to 85% at plasma concentration of 300 mcg/mL. Over a 0.15 to 3 g dose range in healthy adult subjects, the apparent volume of distribution ranged from 5.8 to

13.5L. Ceftriaxone crosses the blood placenta barrier. Ceftriaxone penetrates the inflamed meninges of infants and pediatric patients.

The average values of maximum plasma concentration, cerebrospinal fluid (CSF) concentrations, elimination half-life, plasma clearance and volume of distribution after a 50 mg/kg intravenous dose and after a 75 mg/kg intravenous dose in pediatric patients suffering from bacterial meningitis are shown in Table 4. TABLE 4: Average Pharmacokinetic Parameters of Ceftriaxone in Pediatric Patients with Meningitis 50 mg/kg I.V. 75 mg/kg I.V.

Maximum Plasma Concentrations (mcg/mL) 216 275 Elimination Half-life (hr) 4.6

4.3Plasma Clearance (mL/hr/kg) 49 60 Volume of Distribution (mL/kg) 338 373 CSF Concentration – inflamed meninges (mcg/mL) 5.6

6.4Range (mcg/mL) 1.3-18.5 1.3-44 Time after dose (hr) 3.7 (±1.6) 3.3 (±1.4) After a 1 gram intravenous dose, average concentrations of ceftriaxone, determined from 1 to 3 hours after dosing, were 581 mcg/mL in the gallbladder bile, 788 mcg/mL in the common duct bile, 898 mcg/mL in the cystic duct bile, 78.2 mcg/gram in the gallbladder wall compared to a corresponding concentration of 62.1 mcg/mL in plasma. Excretion Ceftriaxone concentrations in urine are shown in Table 5. TABLE 5: Urinary Concentrations of Ceftriaxone After Single Dose Administration Average Urinary Concentrations (mcg/mL) Dose/Route 0-2 hr 2-4 hr 4-8 hr 8-12 hr 12-24 hr 24-48 hr 0.5 gram I.V.

526 366 142 87 70 15 1 gram I.V. 995 855 293 147 132 32 2 grams I.V. 2692 1976 757 274 198 40 Thirty-three percent to 67% of a ceftriaxone dose was excreted in the urine as unchanged drug, and the remainder was secreted in the bile and ultimately found in the feces as microbiologically inactive compounds.

The elimination of ceftriaxone is not altered by probenecid. Special Populations Average pharmacokinetic parameters of ceftriaxone in healthy subjects, elderly subjects, subjects with renal impairment, and subjects with liver disease are summarized in Table 6. Compared to healthy adult subjects, the pharmacokinetics of ceftriaxone were only minimally altered in elderly subjects and in patients with renal or hepatic impairment; therefore, dosage adjustments are not necessary for these patients with ceftriaxone dosages up to 2 grams per day.

Ceftriaxone was not removed to any significant extent from the plasma by hemodialysis. In 6 of 26 dialysis patients, the elimination rate of ceftriaxone was markedly reduced, suggesting that plasma concentrations of ceftriaxone should be monitored in these patients to determine if dos…

🧬 Mechanism of Action 13 words ▾

12.1Mechanism of Action Ceftriaxone is an antibacterial drug. [see Microbiology (12.4) ]

📦 How Supplied / Storage and Handling 124 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ceftriaxone for Injection, USP is available in the following SmartPak ® Pharmacy Bulk Package bags: 100 grams* One Pharmacy Bulk Package bag Product No. 6100 NDC 66288-6100-1. *Each 100 gram Pharmacy Bulk Package bag contains sterile ceftriaxone sodium equivalent to 100 grams of ceftriaxone SmartPak ® system components are not made with natural rubber latex. Precautions As with other cephalosporins, reconstituted Ceftriaxone for Injection tends to darken depending on storage conditions within the stated recommendations.

However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter. Storage Conditions Prior to reconstitution, store Ceftriaxone for Injection sterile powder at room temperature 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] and protected from light.

📋 Description ~2 min read ▾

11 DESCRIPTION Ceftriaxone for Injection, USP, Pharmacy Bulk Package bag SmartPak ® should be used only in patients who require a 1 gram dose and not any fraction thereof. Ceftriaxone for Injection USP, Pharmacy Bulk Package bag SmartPak ® should not be used in patients who require less than the 1 gram dose of ceftriaxone. Ceftriaxone for Injection, USP, is a sterile, semisynthetic, broad-spectrum cephalosporin antibacterial for intravenous administration.

Ceftriaxone sodium is (6 R ,7 R )-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as -triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2 -( Z )-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18 H 16 N 8 Na 2 O 7 S 3 •3.5H 2 O. It has a calculated molecular weight of 661.60 and the following structural formula: Ceftriaxone sodium is a white to yellowish-orange crystalline powder, which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol.

The p H of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration. Each Pharmacy Bulk Package contains approximately 83 mg (3.6 mEq) of sodium per 1 gram of ceftriaxone activity.

Ceftriaxone for Injection, USP is supplied in 100 grams SmartPak ® Pharmacy Bulk Packages bags equivalent. Each SmartPak ® Pharmacy Bulk Package bag contains ceftriaxone sodium, USP equivalent to 100 grams of ceftriaxone. BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY OVER 30 MINUTES.

THIS PRODUCT IS NOT INTENDED TO BE USED IN PEDIATRIC PATIENTS AND RENALLY IMPAIRED PATIENTS WHO REQUIRE LESS THAN A 1 GRAM DOSE. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients that neurological adverse reactions could occur with Ceftriaxone for Injection use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and non-convulsive status epilepticus, for immediate treatment, or discontinuation of Ceftriaxone for Injection [see Warnings and Precautions (5.3) ].

Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions require immediate treatment and discontinuation of ceftriaxone. Patients should report to their health care provider any previous allergic reactions to ceftriaxone, cephalosporins, penicillins, or other similar antibacterials. Advise patients of neurological adverse reactions that could occur with Ceftriaxone for Injection, USP use.

Instruct patients to inform a healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures, for immediate treatment, dosage adjustment, or discontinuation of Ceftriaxone for Injection, USP. Patients should be advised that 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 a physician as soon as possible. Patients should be counseled that antibacterial drugs including ceftriaxone, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When Ceftriaxone for Injection, USP 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 ceftriaxone or other antibacterial drugs in the future. Rx only SmartPak is a registered trademark of Samson Medical Technologies, L.L.C.

C6100d SAMSON MEDICAL TECHNOLOGIES L.L.C. Cherry Hill, NJ 08003, USA by ACS Dobfar S.p.A. 20067 Tribiano (Milano) Italy Manufactured for

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

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

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

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

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

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

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

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

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

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

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

broad-spectrum: Describes an antibiotic that works against a wide range of different bacteria.

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

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

cholecystitis: Inflammation of the gallbladder, often caused by gallstones blocking it.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

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

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

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

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

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diaphoresis: Heavy or excessive sweating.

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

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

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

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

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

efficacy: How well a treatment works under the controlled conditions of a clinical study.

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

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

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

epistaxis: A nosebleed.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

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

flatulence: Passing gas from the bowel; feeling bloated or gassy.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

glycosuria: Sugar (glucose) in the urine, which often happens when blood sugar is high.

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

hematuria: Blood in the urine.

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

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

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

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

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

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

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

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

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

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

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

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

lymphopenia: A low level of lymphocytes, a type of white blood cell that is important for immune defense.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

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

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

neonatal: Relating to a newborn baby during its first four weeks of life.

nephrolithiasis: Kidney stones; hard mineral deposits that form in the kidneys.

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

oliguria: Producing much less urine than normal, which is often a sign the kidneys are under stress.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

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

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

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

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

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

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pruritus: Itching of the skin.

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

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

septicemia: An older term for blood poisoning, meaning germs have gotten into the bloodstream and are multiplying there.

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

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

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

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

thrombocytosis: A higher-than-normal level of platelets, the blood cells that help form clots.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

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

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

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

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 66288-4100-01 · SAMSON 66288-7100-01 · SAMSON →

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.

Ceftriaxone 100 g Injection, Powder, For Solution, 1 injection

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

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

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class