62135-192 NDC - CALCIUM ACETATE

Drug Information

  • Product NDC: 62135-192
  • Proprietary Name: Calcium Acetate
  • Non Proprietary Name: Calcium Acetate
  • Active Ingredient(s): 667 mg/1 CALCIUM ACETATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Chartwell RX LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA202420
Marketing Category: ANDA
Start Marketing Date:7/1/2019

Package Information

No. Package Code Package Description Billing Unit
162135-192-22200 TABLET in 1 BOTTLE (62135-192-22)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC62135-192This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NAMECalcium AcetateThe 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 AcetateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALName of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE7/1/2019The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEANDAA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
APPLICATION NUMBERANDA202420This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMEChartwell RX LLCThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
SUBSTANCE NAMECALCIUM ACETATEAn 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 STRENGTH667 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESBlood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]The 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.

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This page was last updated on: 11/21/2025

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