63323-064 NDC - MAGNESIUM SULFATE ()

Drug Information

  • Product NDC: 63323-064
  • Proprietary Name: Magnesium Sulfate
  • Non Proprietary Name:
  • Active Ingredient(s): 500 mg/mL MAGNESIUM SULFATE HEPTAHYDRATE500 mg/mL MAGNESIUM SULFATE HEPTAHYDRATE500 mg/mL MAGNESIUM SULFATE HEPTAHYDRATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Calculi Dissolution Agent [EPC]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name Field Value
Labeler Name: Fresenius Kabi USA, LLC
Product Type:
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:8/8/2000
End Marketing Date:11/2/2016

Package Information

No. Package Code Package Description Billing Unit
163323-064-0225 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-02) / 2 mL in 1 VIAL, SINGLE-DOSEML
263323-064-0325 VIAL, SINGLE-DOSE in 1 CARTON (63323-064-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-064-01)ML
363323-064-1025 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-10) / 10 mL in 1 VIAL, SINGLE-DOSEML
463323-064-1125 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-11) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-064-04)ML
563323-064-2025 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-20) / 20 mL in 1 VIAL, SINGLE-DOSEML
663323-064-2325 VIAL, GLASS in 1 TRAY (63323-064-23) / 2 mL in 1 VIAL, GLASS (63323-064-21)ML
763323-064-2625 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-26) / 2 mL in 1 VIAL, SINGLE-DOSEML
863323-064-2925 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-29) / 20 mL in 1 VIAL, SINGLE-DOSEML
963323-064-4325 VIAL, GLASS in 1 TRAY (63323-064-43) / 2 mL in 1 VIAL, GLASS (63323-064-41)ML
1063323-064-5025 VIAL, SINGLE-DOSE in 1 CARTON (63323-064-50) / 50 mL in 1 VIAL, SINGLE-DOSEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC63323-064The 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 NAMEMagnesium SulfateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/8/2000This 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 NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63323-064The 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 NAMEMagnesium SulfateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/8/2000This 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 NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63323-064The 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 NAMEMagnesium SulfateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/8/2000This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63323-064The 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 NAMEMagnesium SulfateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/8/2000This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63323-064The 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 NAMEMagnesium SulfateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/8/2000This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.

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

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