71205-052 NDC - ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)

Drug Information

  • Product NDC: 71205-052
  • Proprietary Name: Rosuvastatin calcium
  • Non Proprietary Name: Rosuvastatin Calcium
  • Active Ingredient(s): 10 mg/1 ROSUVASTATIN CALCIUM
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Proficient Rx LP
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA207752
Marketing Category: ANDA
Start Marketing Date:10/31/2016

Package Information

No. Package Code Package Description Billing Unit
171205-052-3030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-30)EA
271205-052-6060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-60)
371205-052-9090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC71205-052The 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 NAMERosuvastatin calciumThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMERosuvastatin CalciumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe 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 DATE10/31/2016The 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.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA207752The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAMEProficient Rx LPThe translation of the route code submitted by the firm, indicating route of administration.
SUBSTANCE NAMEROSUVASTATIN CALCIUMProduct 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.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 

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This page was last updated on: 12/6/2025

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