Uniferon®​ 200 mg/ml SOLUTION FOR INJECTION Iron(III) as iron(III) hydroxide dextran complex

Uniferon 200 by

Drug Labeling and Warnings

Uniferon 200 by is a Animal medication manufactured, distributed, or labeled by Pharmacosmos A/S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNIFERON 200- iron (iii) hydroxide dextran complex injection, solution 
Pharmacosmos A/S

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Uniferon®​ 200 mg/ml SOLUTION FOR INJECTION Iron(III) as iron(III) hydroxide dextran complex

Each ml contains 200 mg iron(III) as iron(III) hydroxide dextran complex and phenol as a preservative

Read the package leaflet before use

Keep out of the sight and reach of children.

For animal treatment only

Pigs (piglets)

Pharmacosmos A/S

Roervangsvej 30

DK-4300 Holbaek

Shelf life once opened: 28 days below 25°C

Withdraw period: Zero days

Protect from frost

Once opened, use by__/__/__

Batch:

EXP:

Uniferon® 200 Customer Information Sheet

Uniferon® 200 NADA 134-708 Package Insert

Uniferon® 200 NDC: 49442-7401-1

UNIFERON 200 
iron (iii) hydroxide dextran complex injection, solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 49442-7401
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOL (UNII: 339NCG44TV)	5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49442-7401-3	72 in 1 BOX
1	NDC: 49442-7401-2	12 in 1 CARTON
1	NDC: 49442-7401-1	100 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/11/2020	02/26/2024

Labeler - Pharmacosmos A/S (309706968)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacosmos A/S		309706968	api manufacture

Revised: 2/2024

Document Id: e35e4887-7f3a-4110-af76-234a25c405fd

50577-6

Set id: 4fb740c1-39b0-4fb5-8870-487b4137529c

Version: 2

Effective Time: 20240226