NDC 73317-8222 Neonatal Fe

Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid

NDC Product Code 73317-8222

NDC CODE: 73317-8222

Proprietary Name: Neonatal Fe 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, Folic Acid, Cyanocobalamin, Ascorbic Acid 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.
  • Drug uses not available

Product Characteristics

Color(s):
GREEN (C48329)
Shape: ROUND (C48348)
Size(s):
11 MM
Score: 1

NDC Code Structure

  • 73317 - Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals

NDC 73317-8222-3

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Neonatal Fe with NDC 73317-8222 is a a human prescription drug product labeled by Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals. The generic name of Neonatal Fe is iron, folic acid, cyanocobalamin, ascorbic acid. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Neonatal Fe Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FOLIC ACID 1000 ug/1
  • IRON PENTACARBONYL 90 mg/1
  • CYANOCOBALAMIN 12 ug/1
  • ASCORBIC ACID 120 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals
Labeler Code: 73317
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 09-24-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Neonatal Fe Product Label Images

Neonatal Fe 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.

Product Labeling Index

Description

Each green film-coated tablet for oral administration contains:Iron (Ferronyl)  90 mgFolic Acid  1000 mcgVitamin B12 (Cyanocobalamin)  12 mcgVitamin C (Ascorbic acid)  120 mgInactive Ingredients: Microcrystalline cellulose, DI-Calcium phosphate, stearic acid, magnesium stearate, croscarmellose sodium, silicon dioxide, Titanium dioxide, HPMC E15, HPMC E5/E6, FD&C YELLOW # 5(LAKE), FD&C BLUE # 1 (LAKE ), FD&C YELLOW # 6 (LAKE).

Clinical Pharmacology

Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

Indications

NEONATAL FE Rx Prenatal Vitamin With ferronyl iron Vitamin is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs.

Contraindications

Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Warning

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.WarningAccidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions

Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.GeneralTake 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with NEONATAL FE tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment.Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.Folic AcidFolic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.Pediatric UseSafety and effectiveness in pediatric patients have not been established.Geriatric UseDosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

Adverse Reactions

Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.DRUG INTERACTIONSPrescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.OVERDOSAGESymptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

Dosage And Administration

One tablet daily or as directed by a physician.NOTICEContact with moisture can discolor or erode the tablet. Do not chew tablet.

How Supplied

  • NEONATAL FE (NDC 73317-8222-3) is a green, round shaped, film-coated tablet and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature).To report a serious adverse event or obtain product information, call 866-760-6565Dispensed by PrescriptionThis product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.1. Federal Register Notice of August 2, 1973 (38 FR 20750)2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)3. Federal Register Notice of March 5, 1996 (61 FR 8760)AUM Pharmaceuticals does not represent these product codes to be National Drug Codes (NDC) .Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply chain control including pharmacies.THERAPEUTIC GUIDELINES FOR THE PATIENTSome facts you should know about Iron Deficiency AnemiaIron Deficiency Anemia, or IDA, is a common type of anemia. It's a condition in which blood lacks an adequate supply of healthy red blood cells. These cells carry oxygen to tissues. It is oxygenated blood that gives your body energy and your skin a healthy color.As the name suggests, Iron Deficiency Anemia results from insufficient iron. Your body needs iron to make a substance called hemoglobin. It's the hemoglobin in red blood cells that enables them to carry oxygen.What causes IDA?There are many causes of IDA. These include:A diet consistently low in ironBlood loss due to heavy menstrual bleedingPoor iron absorption from food due to intestinal surgery or diseases of the intestinePregnancy (when the need for iron increases significantly)Women in general are at higher risk of IDA, not only because they lose blood during menstruation but also because their bodies store less iron.How common is it?IDA is a common nutritional deficiency, with women most widely affected. Up to 20% of women have IDA.What are the symptoms?Some of the symptoms most commonly associated with IDA are fatigue, weakness, and headache. Symptoms may also include light-headedness, pale skin, shortness of breath, and cold hands and feet, among others. As the body becomes more deficient in iron and anemia worsens, the symptoms worsen as well.How is IDA diagnosed?A diagnosis is made primarily through blood tests. The doctor checks your hematocrit, the percentage of your blood volume made up of red blood cells and hemoglobin. A lower than normal hemoglobin level indicates anemia. Also, blood tests for IDA typically include a measurement of ferritin, a protein that helps store iron in your body. When the level of ferritin is low, usually the level of iron is, too. If a patient tests positive for IDA, additional tests may be ordered to identify an underlying cause.Does IDA lead to health complications?Mild cases of IDA usually don't cause complications. However, left untreated, IDA can increase in severity and contribute to serious health problems. For example, it may lead to a rapid or irregular heartbeat, a complicated pregnancy that can put the mother at risk for a premature delivery or low-birth-weight baby, and delayed growth in infants and children. The good news is that, because IDA is easily treatable, its potential health consequences are generally avoidable.How is IDA treated?It's essential to increase the amount of iron in your diet. Foods rich in iron include meat, fish, poultry, and whole grain breads. However, in most cases of IDA, diet alone isn't enough to correct the problem. Iron supplementation is usually needed for several months. Your doctor has prescribed NEONATAL FE, a safe and effective iron supplement to help restore your body's iron to normal levels. Plus, it offers the convenience of once-daily dosing. Together with an iron-rich diet, taking NEONATAL FE every day can make a big difference in helping restore your body's iron, and with it your energy and overall feeling of well-being.If you have questions about NEONATAL FE please call: 866-760-6565AUM Pharmaceuticals320 Oser Ave,Hauppauge, NY 11788-3608

* Please review the disclaimer below.