LINCOMYCIN 300 INJECTION

Manufacturer
Aspen Veterinary Resources, Ltd.
Effective date
2024-03-20
Label type
OTC ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:42:55

Label at a glance#

ProductLINCOMYCIN
Active ingredientLINCOMYCIN HYDROCHLORIDE
Label structure12 sections

Storage and handling

Store at controlled room temperature: 20 o to 25 o C (68 o to 77 o F) [See USP]

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Sterile Lincomycin Hydrochloride Injection

Swine Antibiotic

300 mg/mL

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Not for Use in Humans
Keep out of reach of children

Approved by FDA under ANADA # 200-315

NET CONTENTS:

3.38 fl oz (100 mL)

For Intramuscular Use in Swine
Over 300 lbs. Restricted Drug - Use
Only As Directed (California).
For Use in Animals Only.

Lincomycin Injectable brand of Lincomycin hydrochloride injectable 

For Intramuscular Use in Swine Only

Lincomycin Injectable contains lincomycin hydrochloride, an antibiotic produced by Streptomyces lincolnensis var. lincolnensis, which is chemically distinct from all other clinically available antibiotics and is isolated as a white crystalline solid.

INDICATIONS FOR SWINE

INDICATIONS & USAGE SECTION

Lincomycin Injectable is indcated fot he treatmen of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides in swine, such as staphylococci, streptococci, Erysipelothrix and Mycoplasma ssp.

It is also indicated for the treatment of mycoplasma pneumonia.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

As with all drugs, the use of Lincomycin Injectable is contraindicated in animals previously found to be hypersensitive to the drug. 

WARNING

WARNINGS SECTION

Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment.  Not for human use.

CAUTION

If no improvement is noted within 48 hours, consult a veterinarian.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The intramuscular administration to swine may cause a transient diarrhea or loose stools. Although this effect has rarely been reported, one must be alert to the possibility that it may occur. Should this occur, it is important that the necessary steps be taken to prevent the effects of dehydration.

CONTACT INFORMATION

SPL UNCLASSIFIED SECTION

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Sparhawk Laboratories Inc at 1-800-255-6388 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

HOW SUPPLIED

HOW SUPPLIED SECTION

Lincomycin Injectable is available in three concentrations: 300 mg/mL, 100 mg/mL and 25 mg/mL.

300 mg/mL: For use in swine weighing 300 pounds or more. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 300 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

100 mg/mL: Each mL contains lincomycin hydrochloride equivalent to lincomycin , 100 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

25 mg/mL: Special baby pig concentration. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 25 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

WARNINGS SECTION

Indicated for the treatment of arthritis caused by susceptible organisms and for mycoplasma pneumonia.

Warning: Not for human use. Keep out of reach of children. Swine intended for human consumption shold not be slaughtered within 48 hours of latest treatment.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

For Intramuscular Use in Swine Over 300 lbs.

For Use in Animals Only.

Usual daily dose for arthritis or mycoplasma pneumonia - 5 mg per pound of body weight (1 mL per each 60 pounds of body weight) intramuscularly for three to seven days. See package insert for ocmplete product information.

DOSAGE AND ADMINISTRATION For arthritis or mycoplasma pneumonia - 5 mg per pound of body weight intramuscularly once daily for three to seven days as needed. When using Lincomycin Injectable containing 25 mg/mL, 1 mL/5 lb. body weight will provide 5 mg/lb.
When using Lincomycin Injectable containing 100 mg/mL, 1mL/20lb body weight will provide 5mg/lb. When using Lincomycin Injectable containing 300 mg/mL, 1 mL/60 lb. body weight will provide 5 mg/lb. For optimal results, initiate treatment as soon as possible. As with any multi-dose vial, practice aseptic techniques in withdrawing each dose. Adequately clean and disinfect the vial closure prior to entry with a sterile needle and syringe. No vial closure should be entered more than 20 times.

Contains per mL

DESCRIPTION SECTION

Lincomycin Hydrochloride equivalent to Lincomycin 300 mg; also Benzyl Alcohol, 9.45 mg added as preservative.

STORAGE AND HANDLING SECTION

Store at controlled room temperature: 20o to 25oC (68o to 77oF) [See USP]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lincomycin 300 100 mLLincomycin 300 100 mLLincomycin 300 100 mLLincomycin 300 100 mLLincomycin 300 100 mLLincomycin 300 100 mLLincomycin 300 100 mLLincomycin 300 100 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
239212lincomycin 300 MG/ML Injectable SolutionPSN6
239212lincomycin 300 MG/ML Injectable SolutionSCD6
239212lincomycin (as lincomycin HCl) 300 MG/ML Injectable SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
673b6365-42b3-455d-b9d1-7358f1db4536Product name420231212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46066-246-04LINCOMYCIN100 mL in 1 VIALINJECTION1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46066-246LINCOMYCIN (LINCOMYCIN) INJECTION [ASPEN VETERINARY RESOURCES, LTD.]61 package rows20240322_ef38a4ca-c9de-4e54-9c70-2b51f1fc343a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LINCOMYCIN HYDROCHLORIDEACTIVE INGREDIENTM6T05Z2B681
LINCOMYCINACTIVE MOIETYBOD072YW0F1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46066-24646066-246-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINCOMYCIN HYDROCHLORIDEM6T05Z2B68ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LincomycinLINCOMYCINMicro Labs Limited20c0e8af-a78f-47f8-ace4-06b80def70032026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincomycin
LINCOMYCINLINCOMYCIN HYDROCHLORIDEHenry Schein, Inc.a7692968-7ac8-48ab-89a4-27c7803e31f42025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LINCOMYCIN
generic name: LINCOMYCIN HYDROCHLORIDE
LincocinLINCOMYCIN HYDROCHLORIDEPharmacia & Upjohn Company LLCc01906fa-2c73-4c13-9765-2fd06628d2632025-03-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma23f9608c-3126-35db-e063-6294a90af0542024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincomycin
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCINArmas Pharmaceuticals Inc.ebabccf4-f082-4fc0-9223-f4826dc89b132023-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincomycin
LincomycinLINCOMYCINArmas Pharmaceuticals Inc.fd2838b7-f8c9-4049-a306-ea620a9c0fe22023-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincomycin
lincomycinLINCOMYCINSlate Run Pharmaceuticals, LLC7efe038a-8d67-4151-864a-b4863b46643e2023-03-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: lincomycin
LincomycinLINCOMYCIN HYDROCHLORIDESagent Pharmaceuticals75e149cc-b668-427e-bae7-a0d215e4fb7a2023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincomycin
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.61f4851d-d919-400d-912a-05eb9dca11d42022-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lincomycin
generic name: LINCOMYCIN HYDROCHLORIDE
lincomycin hydrochlorideLINCOMYCIN HYDROCHLORIDEGland Pharma Limitedc2b5be20-cc6f-4221-9d3e-3f8b5886cd052022-09-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.