LincoMed 100

Manufacturer
Bimeda, Inc. | Bimeda-MTC Animal Health
Effective date
2024-03-27
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 21:07:17

Label at a glance#

ProductLincoMed 100
Active ingredientLINCOMYCIN HYDROCHLORIDE
Label structure11 sections

Storage and handling

STORE AT 20⁰C - 25⁰C (68⁰F - 77⁰F).  KEEP FROM FREEZING

Label contents#

Full prescribing information#

DESCRIPTION SECTION

LincoMed® 100
(lincomycin injection)
For Intramuscular Use in Swine Only

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

LincoMed 100 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 & USAGE SECTION

INDICATIONS FOR SWINE:

LincoMed 100 is indicated for the treatment 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 spp.
It is also indicated for the treatment of mycoplasma pneumonia.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS:

As with all drugs, use of LincoMed 100 is contraindicated in animals previously found to be hypersensitive to the drug.

RESIDUE WARNING SECTION

Residue Warning: Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment.

WARNINGS SECTION

Human Warnings: Not for use in humans. Keep out of reach of children.

CAUTION:

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

ADVERSE REACTIONS SECTION

ADVERSE REACTIONS:

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.

The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

DOSAGE & ADMINISTRATION SECTION

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. One mL per 20 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.

Each mL contains:

Lincomycin hydrochloride equivalent to lincomycin 100 mg; also benzyl alcohol 9.45 mg added as a preservative.

HOW SUPPLIED SECTION

HOW SUPPLIED:

LincoMed is available in two concentrations: 100 mg/mL and 300 mg/mL.

100mg/mL: Supplied in 100 mL multiple dose vial.

300 mg/mL: For use in swine weighing 300 pounds or more. Supplied in 100 mL multiple dose vial.

STORAGE AND HANDLING SECTION

STORE AT 20⁰C - 25⁰C (68⁰F - 77⁰F). KEEP FROM FREEZING

SPL UNCLASSIFIED SECTION

Approved by FDA under ANADA # 200-368

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61133-6000LINCOMED 100 (LINCOMYCIN) INJECTION [BIMEDA, INC.]16Unmatched20240328_4c35730f-62b9-422f-8eb9-6cc4bbbeaaa7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LINCOMYCIN HYDROCHLORIDEACTIVE INGREDIENTM6T05Z2B685
LINCOMYCINACTIVE MOIETYBOD072YW0F5

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61133-600061133-6000-1

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 · Source PDF

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LINCOMYCINLINCOMYCIN HYDROCHLORIDEHenry Schein, Inc.a7692968-7ac8-48ab-89a4-27c7803e31f42025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
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
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDESagent Pharmaceuticals75e149cc-b668-427e-bae7-a0d215e4fb7a2023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINCOMYCIN HYDROCHLORIDE
LincomycinLINCOMYCIN HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.61f4851d-d919-400d-912a-05eb9dca11d42022-10-14Boxed warning, Warnings, Adverse reactionsName fallback
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.