NDC 00404-9901-10 — LINCOMYCIN 300 mg/mL Injection, Solution

🆔 Identity & classification

FDA NDC (as labeled) 0404-9901-10

Product NDC 0404-9901

11-digit billing NDC 00404990110

RxCUI 239212

UNII M6T05Z2B68

Application # ANDA201746

SPL Set ID a7692968-7ac8-48ab-89a4-27c7803e31f4

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-01-12

Route INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL

Dosage form INJECTION, SOLUTION

Substance LINCOMYCIN HYDROCHLORIDE

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 0404-9901-10 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00404-9901-10. 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 Lincosamides class.

Drug family (ATC) Lincosamides

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

LabelerHenry Schein, Inc.

Application holderXGEN PHARMACEUTICALS DJB INC

FDA applicationANDA201746 (ANDA)

Labeler code00404

First marketedJan 2022

Product typeHuman Prescription Drug

Portfolio172 products on file

🔎 All NDCs from Henry Schein, Inc.

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

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

7

Nutrient depletion considerations

Lincomycin HCl 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 Lincomycin HCl 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

9.45 mg / 1 mL UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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 · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2010	$4.234 / J2010 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)0404-9901-10

11-digit billing NDC00404-9901-10

Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)

HCPCS J-codeJ2010

DescriptorInjection, lincomycin hcl, up to 300 mg

Billing units / pkg10 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Lincocin 300 mg/mL 00009-0104-04	Pharmacia	1 vial	—	AP	FDA listed	—
Lincocin 300 mg/mL 00009-0107-04	Pharmacia	1 vial	—	AP	FDA listed	—
Lincomycin 3000 mg/10mL 00121-1035-55	PAI	10 vials	—	AP	FDA listed	—
Lincomycin 300 mg/mLthis 00404-9901-10	Henry	1 vial	—	AP	FDA listed	—
Lincomycin 300 mg/mL 25021-0193-02	Sagent	10 vials	—	AP	FDA listed	—
Lincomycin 300 mg/mL 39822-0350-02	XGen	10 vials	—	AP	FDA listed	—
Lincomycin 300 mg/mL 39822-0353-06	XGen	10 ml	—	AP	FDA listed	—
Lincomycin 300 mg/mL 42571-0374-75	Micro	1 vial	—	AP	FDA listed	—
lincomycin hydrochloride 300 mg/mL 68083-0478-01	Gland	1 vial	—	AP	FDA listed	—
Lincomycin hydrochloride 300 mg/mL 68083-0479-01	Gland	1 vial	—	AP	FDA listed	—
lincomycin 300 mg/mL 70436-0034-82	Slate	10 vials	—	—	FDA listed	—
lincomycin 300 mg/mL 70436-0035-80	Slate	1 vial	—	—	FDA listed	—
Lincomycin 600 mg/2mL 72485-0114-01	Armas	1 vial	—	AP	FDA listed	—
Lincomycin 3000 mg/10mL 72485-0115-10	Armas	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

🏛️

2022

On the market since

Jan 2022

📍

2026

Currently FDA-listed

4 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.

🔬 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 Lincomycin (this brand).

Top reported reactions

Drug Hypersensitivity24

Diarrhoea14

Cellulitis11

Pyrexia10

Stevens-johnson Syndrome10

Liver Injury9

Rash9

Age at onset

Child1

Adult6

Elderly7

Reporter sex

Male · 46%

Female · 52%

Unknown · 2%

Serious outcomes

Hospitalization66

Life-threatening24

Death19

Disabling3

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
00404-9901-10 You're viewing this	1 VIAL in 1 BAG (0404-9901-10) / 10 mL in 1 VIAL	2022-01-12	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)	✓ 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)	— 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 0404-9901-10, 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: 00404-9901-10, written without dashes as 00404990110. 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 00404-9901-10, the first segment (00404) is the labeler code FDA assigned to Henry Schein, Inc.; the middle segment (9901) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Henry Schein, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code J2010 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.

🚨 Boxed Warning ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🚨 Boxed Warning 212 words ▾

BOXED WARNINIG WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin 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. Because lincomycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section.

It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C.diffficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISRATION If significant diarrhea occurs during therapy, this antibacterial should be discontinued. (See WARNING box.) INTRAMUSCULAR-Adults: Serious infections —600 mg (2 mL) intramuscularly every 24 hours. More severe infections —600 mg (2 mL) intramuscularly every 12 hours or more often.

Pediatric patients over 1 month of age : Serious infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often. INTRAVENOUS Adults: The intravenous dose will be determined by the severity of the infection.

For serious infections doses of 600 mg of lincomycin (2 mL of Lincomycin Injection) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations, daily intravenous doses of as much as 8 grams have been given.

Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 mL of appropriate solution (see PHYSICAL COMPATIBILITIES) and infused over a period of not less than one hour. These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin. Pediatric patients over 1 month of age: 10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults.

NOTE: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate. SUBCONJUNCTIVAL INJECTION- 0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibacterial (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens. Patients with diminished renal function: When therapy with Lincomycin is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys.

Image2.jpg

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

⚠️ Warnings ~2 min read ▾

WARNINGS See WARNING Box. Clostridium difficile associated diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Hypersensitivity Serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of Lincomycin Injection. If an allergic reaction to Lincomycin occurs, discontinue the drug. (See ADVERSE REACTIONS ) Benzyl Alcohol Toxicity in Pediatric Patients ("Gasping Syndrome") Lincomycin Injection Sterile Solution contains benzyl alcohol as a preservative.

The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidney's capacity to detoxify the chemical.

Premature and low-birth weight infants may be more likely to develop toxicity. Use in Meningitis — Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis.

🤒 Adverse Reactions 211 words ▾

ADVERSE REACTIONS The following reactions have been reported with the use of lincomycin and are listed by System Organ Class. Frequencies are defined as: commom (≥1% and<10%) uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%) and not known (cannot be estimated from the available data). Gastrointestinal disorders Common: persistent diarrhea (4.3%), nausea (1.8%), vomiting (1.6%) Rare: stomatitis (0.04%) Not known: glossitis, abdominal discomfort, and pruritus Skin and subcutaneous tissue disorders Uncommon: rash (0.8%), urticaria (0.1%) Rare: pruritus (0.4%) Infections and infestations Uncommon: vaginal infection (0.12%) Not known: pseudomembranous colitis, Clostridium difficile colitis (see WARNINGS ) Blood and lymphatic system disorders Not known: pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura Immune system disorders Not known: anaphylactic reaction (see WARNINGS ) angioedema, serum sickness Hepatobiliary disorders Not known: jaundice, liver function test abnormal, transaminases increased Renal and urinary disorders Not known: renal impairment, oliguria, proteinuria, azotemia ¹No direct relationship of LINCOCIN to renal damage has been established.

Cardiac disorders Not known: cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION) Vascular disorders Not known: hypotension (see DOSAGE AND ADMINISTRATION ), thrombophlebitis² ²Event has been reported with intravenous injection. Ear and labyrinth disorders Not known: vertigo, tinnitus Not known: injection site abscess sterile³, injection site induration³, injection site pain³, injection site irritation³ ³Reported with intramuscular injection.

🆘 Overdosage 14 words ▾

OVERDOSAGE Serum levels of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMAcOLOGY Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum concentrations of 11.6 µg/mL at 60 minutes and maintains therapeutic concentrations for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent). A two hour intravenous infusion of 600 mg of lincomycin achieves average peak serum concentrations of 15.9 µg/mL and yields therapeutic concentrations for 14 hours for most susceptible gram-positive organisms.

Urinary excretion ranges from 4.9 to 30.3 percent (mean: 13.8 percent). The biological half-life after intramuscular or intravenous administration is 5.4 ± 1.0 hours. The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function.

In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum. Tissue level concentrations indicate that bile is an important route of excretion.

Significant concentrations have been demonstrated in the majority of body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), concentrations of lincomycin in the CSF appear inadequate for the treatment of meningitis. Microbiology: Lincomycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections: (see INDICATIONS AND USAGE).

Staphylococcus aureus Streptococcus pneumoniae The following in vitro data are available; but their clinical significance is unknown. Lincomycin has been shown to be active in vitro against the following microorganisms; however, the safety and efficacy of Lincomycin in treating clinical infections due to these organisms have not been established in adequate and well controlled trials. Gram-positive bacteria:: Corynebacterium diphtheriae Streptococcus pyogenes Viridans group streptococci Anaerobic bacteria: Clostridium tetani Clostridium perfringens Cross resistance has been demonstrated between clindamycin and lincomycin.

Resistance is most often due to methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit, which can determine cross resistance to macrolides and streptogramins B (MLS phenotype). Macrolide-resistant isolates of these organisms should be tested for inducible resistance to lincomycin/clindamycin using the D-zone test or other appropriate method. There are currently no antimicrobial susceptibility testing (AST) interpretive criteria for Lincomycin.

📦 How Supplied / Storage and Handling 129 words ▾

HOW SUPPLIED Lincomycin Injection, USP is available in the following strength and package sizes: 300 mg/mL 2 mL Vials NDC 39822-0350-1 Packaged as 10 vials per carton NDC 39822-0350-2 10 mL Vials NDC 39822-0353-5 Packaged as 10 vials per carton NDC 39822-0353-6 Each mL of Lincomycin Injection, USP contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 39822-0353-6 10 Pack NDC 0404-9901-10 1 10 mL Vial in a bag (Vial bears NDC 39822-0353-5) 300 mg/mL

📋 Description 109 words ▾

DESCRIPTION Lincomycin Injection is a sterile solution which contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate.

The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below: Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory.

Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Image1.jpg

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.

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.

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.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

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

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.

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

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

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

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

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.

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

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

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

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

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.

intramuscular: An injection given deep into a muscle; often written as IM.

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.

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

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

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.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

proteinuria: Protein leaking into the urine, which can be a sign that the kidneys' filters are damaged.

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.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

refractory: Describing a disease that does not respond to, or improve with, treatment.

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

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.

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

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

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

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

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

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