15370-103 NDC - QUFLORA PEDIATRIC (VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE)

Drug Information

  • Product NDC: 15370-103
  • Proprietary Name: Quflora Pediatric
  • Non Proprietary Name: VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
  • Active Ingredient(s): 15 [iU]/1 .ALPHA.-TOCOPHEROL, DL-; 60 mg/1 ASCORBIC ACID; 400 [iU]/1 CHOLECALCIFEROL; 1 mg/1 CUPRIC SULFATE; 4 ug/1 CYANOCOBALAMIN; 100 ug/1 FOLIC ACID; 108 ug/1 LEVOMEFOLIC ACID; 15 mg/1 MAGNESIUM OXIDE; 5 mg/1 NIACINAMIDE; 1.5 mg/1 PYRIDOXINE HYDROCHLORIDE; 1.3 mg/1 RIBOFLAVIN; .25 mg/1 SODIUM FLUORIDE; 1.2 mg/1 THIAMINE HYDROCHLORIDE; 1200 [iU]/1 VITAMIN A ACETATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, CHEWABLE
  • Pharmacy Class(es): Analogs/Derivatives [Chemical/Ingredient]; Ascorbic Acid [CS]; Calculi Dissolution Agent [EPC]; Folate Analog [EPC]; Folic Acid [CS]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Vitamin A [CS]; Vitamin A [EPC]; Vitamin B 12 [CS]; Vitamin B 6 [Chemical/Ingredient]; Vitamin B12 [EPC]; Vitamin B6 Analog [EPC]; Vitamin C [EPC]; Vitamin D [CS]; Vitamin D [EPC]

Labeler Information

Field Name Field Value
Labeler Name: CarWin Pharmaceutical Associates, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:1/6/2014

Package Information

No. Package Code Package Description Billing Unit
115370-103-3030 TABLET, CHEWABLE in 1 BOTTLE (15370-103-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC15370-103The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEQuflora PediatricThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, CHEWABLEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/6/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMECarWin Pharmaceutical Associates, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME.ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATEAn 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.
ACTIVE NUMERATOR STRENGTH15; 60; 400; 1; 4; 100; 108; 15; 5; 1.5; 1.3; .25; 1.2; 1200 
ACTIVE INGRED UNIT[iU]/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 
PHARM CLASSESAnalogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC] 

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This page was last updated on: 4/4/2025

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