42192-341 NDC - PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT)

Drug Information

Product NDC: 42192-341

Proprietary Name: Prenaissance

Non Proprietary Name: CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT

Active Ingredient(s):
  • 30 [iU]/1 .ALPHA.-TOCOPHEROL, D-;
  • 28 mg/1 ASCORBIC ACID;
  • 800 [iU]/1 CHOLECALCIFEROL;
  • 325 mg/1 DOCONEXENT;
  • 55 mg/1 DOCUSATE SODIUM;
  • 29 mg/1 FERROUS FUMARATE;
  • 1.25 mg/1 FOLIC ACID;
  • 25 mg/1 PYRIDOXINE HYDROCHLORIDE;
  • 160 mg/1 TRICALCIUM PHOSPHATE


Administration Route(s): ORAL

Dosage Form(s): CAPSULE, LIQUID FILLED

Pharmacy Class(es):
  • Analogs/Derivatives [Chemical/Ingredient];
  • Ascorbic Acid [CS];
  • Blood Coagulation Factor [EPC];
  • Calcium [CS];
  • Cations;
  • Divalent [CS];
  • Increased Coagulation Factor Activity [PE];
  • Vitamin B 6 [Chemical/Ingredient];
  • Vitamin B6 Analog [EPC];
  • Vitamin C [EPC];
  • Vitamin D [CS];
  • Vitamin D [EPC]

Labeler Information

Labeler Name: Acella Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:6/13/2011

Package Information

No. Package Code Package Description Billing Unit
142192-341-3030 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-341-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC42192-341The 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 NAMEPrenaissanceThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENTThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, LIQUID FILLEDThe 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 DATE6/13/2011This 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 NAMEAcella Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATEAn 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 STRENGTH30; 28; 800; 325; 55; 29; 1.25; 25; 160 
ACTIVE INGRED UNIT[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 
PHARM CLASSESAnalogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023