FDA.reportPublic FDA data

Uniferon 200

Manufacturer
Pharmacosmos, Inc | Pharmacosmos A/S
Effective date
2026-02-24
Label type
OTC ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:46:30

Label at a glance#

ProductUniferon 200
Active ingredientIRON DEXTRAN
Label structure8 sections

Storage and handling

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

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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

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., 120 Headquarters Plaza, Morristown, NJ 07960

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

For use in animals only.

Uniferon 200® Iron Dextran Complex Injection, 200 mg/mL

SPL PATIENT PACKAGE INSERT SECTION

100 mL label onsert:

100 mL label onsert100 mL label onsert

250 mL label onsert:

250 mL label onsert250 mL label onsert

Uniferon 200®Iron Dextran Complex Injection, 200 mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2464307iron-dextran complex 200 MG/ML Injectable Solution [Uniferon]SBD6
2464305iron-dextran complex 200 MG/ML Injectable SolutionSCD6
2464305iron dextran 200 MG per 1 ML Injectable SolutionSY6
2464305iron-dextran complex (iron 200 MG/ML) Injectable solutionSY6
2464307uniferon 200 MG per 1 ML Injectable SolutionSY6
2464307Uniferon 200 MG/ML Injectable SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42552-741-01Uniferon 200100 mL in 1 VIALINJECTION1006
42552-741-02Uniferon 20012 in 1 CARTONINJECTION126
42552-741-03Uniferon 20072 in 1 CASEINJECTION726
42552-741-25Uniferon 200250 mL in 1 VIALINJECTION2506
42552-741-26Uniferon 2006 in 1 CARTONINJECTION66
42552-741-27Uniferon 20024 in 1 CASEINJECTION246

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42552-74142552-741-01, 42552-741-02, 42552-741-03, 42552-741-25, 42552-741-26, 42552-741-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
IRON DEXTRAN95HR524N2MACTIM
PHENOL339NCG44TVIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFEDIRON DEXTRANHenry Schein, Inc.99bf34be-cb8a-46d1-9637-5544dc2da2872026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRON DEXTRAN
IRON DEXTRANIRON DEXTRANHF Acquisition Co LLC, DBA HealthFirst9a4cd424-865d-fdd1-e053-2995a90a00ff2025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRON DEXTRAN
INFeDIRON DEXTRANAllergan, Inc.94b01b1e-794b-4bea-8e24-2e54683fc0232024-08-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRON DEXTRAN

Reported adverse events (FAERS/openFDA)#

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