24658-501 NDC - SIMVASTATIN ()

Drug Information

  • Product NDC: 24658-501
  • Proprietary Name: Simvastatin
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: PuraCap Laboratories, LLC
Product Type:
FDA Application Number: ANDA078034
Marketing Category: ANDA
Start Marketing Date:12/17/2015

Package Information

No. Package Code Package Description Billing Unit
124658-501-101000 TABLET, FILM COATED in 1 BOTTLE (24658-501-10)EA
224658-501-3030 TABLET, FILM COATED in 1 BOTTLE (24658-501-30)EA
324658-501-4545 TABLET, FILM COATED in 1 BOTTLE (24658-501-45)EA
424658-501-9090 TABLET, FILM COATED in 1 BOTTLE (24658-501-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC24658-501The 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.
PROPRIETARY NAMESimvastatinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/17/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAThe 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.
APPLICATION NUMBERANDA078034The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
LABELER NAMEPuraCap Laboratories, LLCName of Company corresponding to the labeler code segment of the Product NDC.

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