54643-9007 NDC - ADULT INFUVITE MULTIPLE VITAMINS (ASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMIN)

Drug Information

  • Product NDC: 54643-9007
  • Proprietary Name: Adult Infuvite Multiple Vitamins
  • Non Proprietary Name: Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
  • Active Ingredient(s): 10 [iU]/10mL .ALPHA.-TOCOPHEROL ACETATE; 200 mg/10mL ASCORBIC ACID; 60 ug/10mL BIOTIN; 200 [iU]/10mL CHOLECALCIFEROL; 5 ug/10mL CYANOCOBALAMIN; 15 mg/10mL DEXPANTHENOL; 600 ug/10mL FOLIC ACID; 40 mg/10mL NIACINAMIDE; 150 ug/10mL PHYTONADIONE; 6 mg/10mL PYRIDOXINE HYDROCHLORIDE; 3.6 mg/10mL RIBOFLAVIN 5'-PHOSPHATE SODIUM; 6 mg/10mL THIAMINE HYDROCHLORIDE; 3300 [iU]/10mL VITAMIN A PALMITATE
  • Administration Route(s): INTRAVENOUS
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): Analogs/Derivatives [Chemical/Ingredient]; Ascorbic Acid [CS]; Increased Prothrombin Activity [PE]; Reversed Anticoagulation Activity [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]; Vitamin K [CS]; Vitamin K [EPC]; Warfarin Reversal Agent [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Sandoz Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021163
Marketing Category: NDA
Start Marketing Date:5/18/2005

Package Information

No. Package Code Package Description Billing Unit
154643-9007-110 VIAL in 1 CARTON (54643-9007-1) / 5 mL in 1 VIALML

NDC Record

Field Name Field Value Definition
PRODUCT NDC54643-9007The 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 NAMEAdult Infuvite Multiple VitaminsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/18/2005This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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.
APPLICATION NUMBERNDA021163This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMESandoz IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATEAn 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 STRENGTH10; 200; 60; 200; 5; 15; 600; 40; 150; 6; 3.6; 6; 3300 
ACTIVE INGRED UNIT[iU]/10mL; mg/10mL; ug/10mL; [iU]/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL 
PHARM CLASSESAnalogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [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], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC] 

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

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