49230-212 NDC - DELFLEX NEUTRAL PH ()

Drug Information

  • Product NDC: 49230-212
  • Proprietary Name: Delflex Neutral pH
  • Non Proprietary Name:
  • Active Ingredient(s): 18.4 mg/100mL CALCIUM CHLORIDE; 4.25 g/100mL DEXTROSE MONOHYDRATE; 5.08 mg/100mL MAGNESIUM CHLORIDE; 538 mg/100mL SODIUM CHLORIDE; 448 mg/100mL SODIUM LACTATE18.4 mg/100mL CALCIUM CHLORIDE; 4.25 g/100mL DEXTROSE MONOHYDRATE; 5.08 mg/100mL MAGNESIUM CHLORIDE; 538 mg/100mL SODIUM CHLORIDE; 448 mg/100mL SODIUM LACTATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Calculi Dissolution Agent [EPC]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name Field Value
Labeler Name: Fresenius Medical Care North America
Product Type:
FDA Application Number: NDA020171
Marketing Category: NDA
Start Marketing Date:8/19/1992
End Marketing Date:10/25/2013

Package Information

No. Package Code Package Description Billing Unit
149230-212-236 BAG in 1 CARTON (49230-212-23) / 2000 mL in 1 BAGML
249230-212-304 BAG in 1 CARTON (49230-212-30) / 3000 mL in 1 BAGML
349230-212-313000 mL in 1 BAG (49230-212-31)
449230-212-313000 mL in 1 BAG (49230-212-31)
549230-212-324 BAG in 1 CARTON (49230-212-32) / 3000 mL in 1 BAG
649230-212-502 BAG in 1 CARTON (49230-212-50) / 5000 mL in 1 BAGML
749230-212-512 BAG in 1 CARTON (49230-212-51) / 5000 mL in 1 BAG
849230-212-522 BAG in 1 CARTON (49230-212-52) / 5000 mL in 1 BAG
949230-212-602 BAG in 1 CARTON (49230-212-60) / 6000 mL in 1 BAG
1049230-212-612 BAG in 1 CARTON (49230-212-61) / 6000 mL in 1 BAG
1149230-212-622 BAG in 1 CARTON (49230-212-62) / 6000 mL in 1 BAG
1249230-212-925 BAG in 1 CARTON (49230-212-92) / 2000 mL in 1 BAGML
1349230-212-945 BAG in 1 CARTON (49230-212-94) / 2500 mL in 1 BAGML
1449230-212-954 BAG in 1 CARTON (49230-212-95) / 3000 mL in 1 BAGML
1549230-212-962000 mL in 1 BAG (49230-212-96)
1649230-212-962000 mL in 1 BAG (49230-212-96)
1749230-212-975 BAG in 1 CARTON (49230-212-97) / 2500 mL in 1 BAG
1849230-212-983000 mL in 1 BAG (49230-212-98)
1949230-212-983000 mL in 1 BAG (49230-212-98)

NDC Record

Field Name Field Value Definition
PRODUCT NDC49230-212The 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 NAMEDelflex Neutral pHThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care North AmericaName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDelflex Neutral pHThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care North AmericaName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDELFLEXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care North AmericaName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDELFLEXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care North AmericaName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDelflex Neutral pHThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care North AmericaName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDelflex Neutral pHThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care North AmericaName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDELFLEXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care Renal Therapies Group, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC49230-212The 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 NAMEDELFLEXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/19/1992This 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.
APPLICATION NUMBERNDA020171This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Medical Care Renal Therapies Group, 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

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