Finazol

Product NDC
59088-008
11-digit product format
590880008
Labeler code
59088
Product ID
59088-008_2657fc47-d75d-ff7d-e063-6394a90a68ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferrous Fumarate, Folate
Dosage form
TABLET
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-10-11
Substance
.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; BORON; CALCIUM CARBONATE; CHOLECALCIFEROL; CHROMIUM NICOTINATE; CUPROUS OXIDE; FERROUS FUMARATE; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; MANGANESE SULFATE; METHYLCOBALAMIN; MOLYBDENUM; NIACINAMIDE; PANTOTHENIC ACID; POTASSIUM CHLORIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC CITRATE
Active strength
45; 200; 100; 25; 100; 10; 37.5; 1; 18; 1000; 50; .75; 26; 25; 22.5; 15; 24.5; 25; 6; 3.35; 30; 3.25; 1500; 30 mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinazolFERROUS FUMARATE, FOLATEPureTek Corporation24290823-022a-433b-e063-6394a90a8fd02024-11-07Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. Precautions: Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and / or supplements should be considered. For use on the order of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Drug Interactions: Finazol™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel). Adverse Reactions: Folate : Allergic sensitizations have been reported following both oral and parenteral administration of folate. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Finazol™ after meals may control occasional gastrointestinal disturbances. Finazol™ is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, eve...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

Adverse Reactions: Folate : Allergic sensitizations have been reported following both oral and parenteral administration of folate. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Finazol™ after meals may control occasional gastrointestinal disturbances. Finazol™ is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Additional Listing Data#

Finished product
Yes
Brand name base
Finazol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VITAMIN A ACETATE45 mg/1
ASCORBIC ACID200 mg/1
CHOLECALCIFEROL100 ug/1
.ALPHA.-TOCOPHEROL ACETATE, DL-25 ug/1
THIAMINE MONONITRATE100 mg/1
RIBOFLAVIN10 ug/1
NIACINAMIDE37.5 ug/1
PYRIDOXINE HYDROCHLORIDE1 mg/1
LEVOMEFOLATE CALCIUM18 mg/1
METHYLCOBALAMIN1000 ug/1
BIOTIN50 mg/1
PANTOTHENIC ACID.75 mg/1
CALCIUM CARBONATE26 ug/1
FERROUS FUMARATE25 ug/1
POTASSIUM IODIDE22.5 mg/1
MAGNESIUM OXIDE15 mg/1
ZINC CITRATE24.5 mg/1
SELENIUM25 ug/1
CUPROUS OXIDE6 mg/1
MANGANESE SULFATE3.35 mg/1
CHROMIUM NICOTINATE30 ug/1
MOLYBDENUM3.25 mg/1
POTASSIUM CHLORIDE1500 ug/1
BORON30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3LE3D9D6OY, PQ6CK8PD0R, 1C6V77QF41, WR1WPI7EW8, 8K0I04919X, TLM2976OFR, 25X51I8RD4, 68Y4CF58BV, A9R10K3F2F, BR1SN1JS2W, 6SO6U10H04, 19F5HK2737, H0G9379FGK, R5L488RY0Q, 1C4QK22F9J, 3A3U0GI71G, K72I3DEX9B, H6241UJ22B, T8BEA5064F, W00LYS4T26

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-008-54Finazol30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-008-54EA - Each59088-0088db1b1a7-5286-4982-9fea-dd34a3157cc512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-008FINAZOL (FERROUS FUMARATE, FOLATE) TABLET [PURETEK CORPORATION]2Current NDC, 1 package rows20241109_24290823-022a-433b-e063-6394a90a8fd0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-008-545908800085430 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) 30 tablet2024-10-11NoNoCurrent