Label: UNIFERON 200- iron dextran complex injection
- NDC Code(s): 42552-741-01, 42552-741-02, 42552-741-03
- Packager: Pharmacosmos, Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 8, 2023
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- GENERAL PRECAUTIONS
- STORAGE AND HANDLING
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SPL UNCLASSIFIED SECTION
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
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- Uniferon® 200 Iron Dextran Complex Injection, 200 mg/mL
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INGREDIENTS AND APPEARANCE
UNIFERON 200
iron dextran complex injectionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:42552-741 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:42552-741-03 72 in 1 CASE 1 NDC:42552-741-02 12 in 1 CARTON 1 NDC:42552-741-01 100 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA134708 06/24/2021 Labeler - Pharmacosmos, Inc (878028943) Establishment Name Address ID/FEI Business Operations Pharmacosmos A/S 309706968 api manufacture