IRON-200 (Iron Hydrogenated Dextran Injection)

Manufacturer
Durvet, Inc. | Sparhawk Laboratories, Inc. | Chemdex Inc.
Effective date
2024-12-02
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:43:56

Label at a glance#

ProductIRON 200
Active ingredientIRON
Label structure9 sections

Storage and handling

Storage, Handling, and Disposal: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Iron-200

For prevention or treatment of nursing
piglet anemia due to iron deficiency.
Approved by FDA under NADA # 138-255
NOT FOR HUMAN USE
KEEP OUT OF REACH OF CHILDREN
For use in animals only

Indications: For prevention or treatment of nursing piglet anemia due to iron deficiency.
Dosage and Administration:
For Intramuscular Injection only.
Prevention: 1 mL (200 mg iron) at 1-3 days of
age. Treatment: 1 mL (200 mg iron) at the first
signs of Iron deficiency.
Notice: Iron hydrogenated dextran injection
injected intramuscularly into nursing piglets may
cause muscle staining that generally resolves
within 14 days after administration.
Refer to onsert and read carefully before use.

Iron-200 Injection 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.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and
86°F).
Use within 24 months of first puncture.

DESCRIPTION SECTION

Approved by FDA under NADA # 138-255

IRON-200 INJECTION
(iron hydrogenated dextran injection)

200mg/mL
Description: Iron Dextrans are sterile solutions containing a complex of ferric hydroxide with a low molecular weight dextran fraction. Iron-200 Injection is equivalent to 200 mg elemental iron per mL with 0.5% phenol as a preservative.

Actions. Injectable Iron-200 Injection is easy and economical to use. Injection into the ham is rapid, safe, effective, quickly absorbed by the blood and goes to work immediately. With injectable Iron-200 Injection, the right dosage can be given to every animal with assurance that it will be utilized. Iron deficiency anemia occurs commonly in the nursing piglet, often within the first few days following birth. As body size and blood volume increase rapidly from the first few days following birth, hemoglobin levels in the blood fall due to diminishing iron reserves which cannot be replaced adequately from iron in the sow’s milk. This natural deficiency lowers the resistance of the nursing piglet and scours, pneumonia or other infections may develop and lead to death of the animal. Nursing piglets not hampered by iron deficiency anemia are more likely to experience normal growth and to maintain their normal level of resistance to disease. Adequate iron is necessary for normal, healthy, vigorous growth.

INDICATIONS & USAGE SECTION

Indications: Iron-200 Injection is intended for the prevention or treatment of anemia in nursing piglets due to iron deficiency.
Notice: Iron hydrogenated dextran injected intramuscularly into nursing piglets may cause muscle staining that generally resolves within 14 days after administration.
Dosage and Administration: For the prevention of anemia due to iron deficiency, administer an intramuscular injection of 200 milligrams of elemental iron (1 mL) at 1 to 3 days of age. For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 milligrams of elemental iron (1 mL) at first signs of anemia.

WARNINGS AND PRECAUTIONS SECTION

Warnings

Withdrawal Periods: No withdrawal period is required when used according to labeling.

User Safety Warnings: Not for use in humans. Keep out of reach of children. To obtain a Safety Data Sheet(s), contact Sparhawk Laboratories Inc at 1-800-255-6388 or at sparhawklabs.com
Animal Safety Warnings: Clinical signs associated with iron toxicity in piglets include convulsion, respiratory distress (tachypnea, dyspnea) injection site reactions (inflammation, infection or necrosis), muscle tremors or weakness, prostration, and death. There is increased risk for iron toxicity in piglets born to sows with vitamin E/ selenium deficiencies.

DOSAGE & ADMINISTRATION SECTION

Directions For Use: Use a clean, sterile syringe and needle (20 gauge, ½” needle); and ensure the injection site is clean and dry. Administer intramuscularly into the back of the ham muscle to a depth of approximately ½ inch (see diagram below). Apply tension to the skin at the injection site by pulling skin and fat downward with pressure from the thumb or fingers.

Injection SiteInjection Site

Iron-200 Injection cannot be considered a substitute for sound animal husbandry. If disease is present in the litter CONSULT A VETERINARIAN.

Side Effects: Occasionally, nursing piglets may show a reaction to injectable iron, clinically characterized by prostration with muscular weakness. In extreme cases, death may result.

SPL UNCLASSIFIED SECTION

Questions/Comments: Contact Sparhawk Laboratories Inc at 1-800-255-6388 or sparhawklabs.com. To report side effects, contact Sparhawk Laboratories Inc at 1-800-255-6388. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or
www.fda.gov/reportanimalae

HOW SUPPLIED SECTION

How Supplied: Iron-200 Injection is available in 100 mL multidose vials.

STORAGE AND HANDLING SECTION

Storage, Handling, and Disposal: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Durvet Iron-200Durvet Iron-200Durvet Iron-200 OnsertDurvet Iron-200 Onsert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2464305iron-dextran complex 200 MG/ML Injectable SolutionSCD1
2464305iron dextran 200 MG per 1 ML Injectable SolutionSY1
2464305iron-dextran complex (iron 200 MG/ML) Injectable solutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30798-345-10IRON200100 mL in 1 VIAL, MULTI-DOSEINJECTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30798-345IRON 200 (IRON) INJECTION [DURVET, INC.]11 package rows20241204_c8e1fc53-1e9b-410d-9b1c-c6a2f3e119a1.zip

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
30798-34530798-345-10

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
IRONE1UOL152H7ACTIB
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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REAL SUMMERIRONKAYONE63021d49-8720-4e4e-a08f-a5d2f6acfaa52024-12-09WarningsName fallback
generic name: IRON
Ferrum Metallicum 6XIRONTrue Botanica, LLC2392929c-996b-01e0-e063-6394a90aa2b92024-10-03WarningsName fallback
generic name: IRON
Ferrum metallicumIRONBoiron85914cb4-f903-80c6-e053-2a91aa0ae14a2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85912948-19cc-76be-e053-2991aa0a3e5a2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron8591b12c-51c8-9839-e053-2a91aa0aa9372023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85917340-1f94-08db-e053-2a91aa0a77c92023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron87372ec7-eacf-90b1-e053-2a91aa0afadf2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron859195ed-0b6c-f4fe-e053-2991aa0ad85b2023-03-03Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85919b82-39cf-254d-e053-2a91aa0a61502023-02-20Name fallback
generic name: IRON

Reported adverse events (FAERS/openFDA)#

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