49230-203 NDC - DELFLEX ()

Drug Information

  • Product NDC: 49230-203
  • Proprietary Name: DELFLEX
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Fresenius Medical Care North America
Product Type:
FDA Application Number: NDA018883
Marketing Category: NDA
Start Marketing Date:11/30/1984
End Marketing Date:8/13/2015

Package Information

No. Package Code Package Description Billing Unit
149230-203-1012 BAG in 1 CARTON (49230-203-10) / 1000 mL in 1 BAG
249230-203-156 BAG in 1 CARTON (49230-203-15) / 1500 mL in 1 BAG
349230-203-206 BAG in 1 CARTON (49230-203-20) / 2000 mL in 1 BAG
449230-203-236 BAG in 1 CARTON (49230-203-23) / 2000 mL in 1 BAG
549230-203-254 BAG in 1 CARTON (49230-203-25) / 2500 mL in 1 BAG
649230-203-304 BAG in 1 CARTON (49230-203-30) / 3000 mL in 1 BAG
749230-203-313000 mL in 1 BAG (49230-203-31)
849230-203-502 BAG in 1 CARTON (49230-203-50) / 5000 mL in 1 BAGML
949230-203-512 BAG in 1 CARTON (49230-203-51) / 5000 mL in 1 BAG
1049230-203-612 BAG in 1 CARTON (49230-203-61) / 6000 mL in 1 BAG
1149230-203-9012 BAG in 1 CARTON (49230-203-90) / 1000 mL in 1 BAG
1249230-203-916 BAG in 1 CARTON (49230-203-91) / 1500 mL in 1 BAG
1349230-203-925 BAG in 1 CARTON (49230-203-92) / 2000 mL in 1 BAG
1449230-203-935 BAG in 1 CARTON (49230-203-93) / 2250 mL in 1 BAG
1549230-203-945 BAG in 1 CARTON (49230-203-94) / 2500 mL in 1 BAG
1649230-203-954 BAG in 1 CARTON (49230-203-95) / 3000 mL in 1 BAG
1749230-203-962000 mL in 1 BAG (49230-203-96)
1849230-203-975 BAG in 1 CARTON (49230-203-97) / 2500 mL in 1 BAG
1949230-203-983000 mL in 1 BAG (49230-203-98)

NDC Record

Field Name Field Value Definition
PRODUCT NDC49230-203The 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 DATE11/30/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/25/2013This 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.
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 NUMBERNDA018883This 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 NDC49230-203The 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 DATE11/30/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE6/30/2016This 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.
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 NUMBERNDA018883This 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 NDC49230-203The 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 DATE11/30/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/25/2013This 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.
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 NUMBERNDA018883This 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 NDC49230-203The 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 DATE11/30/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE5/22/2019This 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.
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 NUMBERNDA018883This 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 NDC49230-203The 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 DATE11/30/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE5/22/2019This 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.
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 NUMBERNDA018883This 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 NDC49230-203The 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 DATE11/30/1984This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE8/13/2015This 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.
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 NUMBERNDA018883This 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.

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This page was last updated on: 7/4/2025

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