76339-511 NDC - SEVELAMER CARBONATE

Drug Information

  • Product NDC: 76339-511
  • Proprietary Name:
  • Non Proprietary Name: Sevelamer Carbonate
  • Active Ingredient(s): 9.999 kg/9.999kg SEVELAMER CARBONATE
  • Administration Route(s):
  • Dosage Form(s): POWDER

Labeler Information

Field Name Field Value
Labeler Name: Apothecon Pharmaceuticals Pvt Ltd
Product Type: BULK INGREDIENT
FDA Application Number:
Marketing Category: BULK INGREDIENT
Start Marketing Date:12/10/2024

Package Information

No. Package Code Package Description Billing Unit
176339-511-001 BAG in 1 DRUM (76339-511-00) / 1 BAG in 1 BAG / .999 kg in 1 BAG
276339-511-011 BAG in 1 DRUM (76339-511-01) / 1 BAG in 1 BAG / 4.999 kg in 1 BAG
376339-511-021 BAG in 1 DRUM (76339-511-02) / 1 BAG in 1 BAG / 9.999 kg in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC76339-511The 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 NAMEBULK INGREDIENTIndicates 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.
NON PROPRIETARY NAMESevelamer CarbonateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE12/10/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBULK INGREDIENTProduct 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 NAMEApothecon Pharmaceuticals Pvt LtdName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESEVELAMER CARBONATEAn 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 STRENGTH9.999 
ACTIVE INGRED UNITkg/9.999kg 

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

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