Se-natal 19 Tablet
NDC 13925-116

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13925-116?
  5. Se-natal 19 Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Se-natal 19 (.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium) is a UNAPPROVED DRUG OTHER-approved product labeled by Seton Pharmaceuticals. This medication is a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 13925-116 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
13925-116
Proprietary Name:
Se-natal 19
Non-Proprietary Name: [1]
.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide And Docusate Sodium
Substance Name: [2]
.alpha.-tocopherol Acetate, Dl-; .beta.-carotene; Ascorbic Acid; Calcium Carbonate; Calcium Pantothenate; Cholecalciferol; Cyanocobalamin; Docusate Sodium; Ferrous Fumarate; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine; Zinc Oxide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Seton Pharmaceuticals
Labeler Code:
13925
Product Label ID:
635104e6-6a53-4684-ac9a-7ac31b33083d
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
07-01-2009
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
TL019
Score:
1

Code Structure Chart

Product Details

What is NDC 13925-116?

The NDC code 13925-116 is assigned by the FDA to the product Se-natal 19. It is commonly known by its generic name, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium. This pharmaceutical product is labeled by Seton Pharmaceuticals and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 13925-116-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins and iron are important building blocks of the body and help keep you in good health.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 30 mg/1
  • .BETA.-CAROTENE 1000 [iU]/1 - A carotenoid that is a precursor of VITAMIN A. Beta carotene is administered to reduce the severity of photosensitivity reactions in patients with erythropoietic protoporphyria (PORPHYRIA, ERYTHROPOIETIC).
  • ASCORBIC ACID 100 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • CALCIUM CARBONATE 200 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
  • CALCIUM PANTOTHENATE 7 mg/1 - A butyryl-beta-alanine that can also be viewed as pantoic acid complexed with BETA ALANINE. It is incorporated into COENZYME A and protects cells against peroxidative damage by increasing the level of GLUTATHIONE.
  • CHOLECALCIFEROL 400 [iU]/1 - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
  • CYANOCOBALAMIN 12 ug/1
  • DOCUSATE SODIUM 25 mg/1 - All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.
  • FERROUS FUMARATE 29 mg/1 - used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt
  • FOLIC ACID 1 mg/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • NIACINAMIDE 15 mg/1 - An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
  • PYRIDOXINE HYDROCHLORIDE 20 mg/1 - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
  • RIBOFLAVIN 3 mg/1 - Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as FLAVIN MONONUCLEOTIDE and FLAVIN-ADENINE DINUCLEOTIDE.
  • THIAMINE 3 mg/1 - 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.
  • ZINC OXIDE 20 mg/1 - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1313925 - alpha-tocopherol acetate 30 UNT / ascorbic acid 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / docusate sodium 25 MG / ferrous fumarate 29 MG / folic acid 1 MG / niacinamide 15 MG / pyridoxine hydrochloride 20 MG / riboflavin 3 MG / thiamine 3 MG / vitamin B12 0.012 MG / zinc oxide 20 MG Oral Tablet
  • RxCUI: 1313925 - alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vitamin B6 hydrochloride 20 MG / riboflavin 3 MG / vitamin B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral Tablet
  • RxCUI: 1313925 - alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vitamin B6 hydrochloride 20 MG / riboflavin 3 MG / vit-B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral Tablet
  • RxCUI: 1313925 - alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vit-B6 hydrochloride 20 MG / riboflavin 3 MG / vitamin B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral Tablet
  • RxCUI: 1313925 - alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vit-B6 hydrochloride 20 MG / riboflavin 3 MG / vit-B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral Tablet

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".