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Animal NDC 42552-741-02 Uniferon 200

Iron Dextran Complex

Animal Product Information

Field Name Field Value
Animal NDC Code 42552-741-02
Proprietary Name Uniferon 200 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Iron Dextran Complex What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Pharmacosmos, Inc
Product Type Otc Animal Drug
Usage Information
    Indications: For prevention or treatment of baby-pig anemia due to iron deficiency.
Active Ingredient(s)
  • Iron Dextran
Inactive Ingredient(s)
  • PHENOL (339NCG44TV)
  • PHENOL (339NCG44TV)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA134708 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Uniferon 200 Images

Uniferon 200 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Indications & Usage



Indications: For prevention or treatment of baby-pig anemia due to iron deficiency.


Dosage & Administration



Dosage and Administration: For Intramuscular Injection only.  Prevention: 1mL (200 mg iron) at 1-3 days of age.  Treatment: 1mL (200mg of iron) at the first signs of Iron deficiency


General Precautions



Caution: Use of this product after four (4) weeks of age may cause staining of the ham muscle.

Refer to folded label attached to this container and read carefully before use.

TAKE TIME.  OBSERVE LABEL DIRECTIONS


Storage And Handling



Store at controlled room temperature 59°-86°F (15°-30°C).


Other



Uniferon® 200 is a sterile solution containing a complex of ferric hydroxide with a low molecular weight dextran fraction equivalent to 200 mg elemental iron per mL with 0.5% phenol as a preservative. Hydrochloric acid and/or sodium hydroxide used for pH adjustment.

Uniferon® is a Trademark of Pharmacosmos A/S.

Manufactured for: Pharmacosmos, Inc., 776 Mountain Boulevard, Watchung, NJ 07069


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.

For use in animals only.


Spl Patient Package Insert



42552-741-01 Uniferon 200 expanded content labeling.jpg


Uniferon® 200 Iron Dextran Complex Injection, 200 Mg/Ml



42552-741-01 Uniferon 200 100mL label.jpg


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.