NDC 49230-212

DELFLEX Neutral pH

Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate

DELFLEX Neutral pH is a Intraperitoneal Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Medical Care North America. The primary component is Dextrose Monohydrate; Sodium Chloride; Sodium Lactate; Calcium Chloride; Magnesium Chloride.

Product ID49230-212_494d8150-addd-11e2-9e96-0800200c9a66
NDC49230-212
Product TypeHuman Prescription Drug
Proprietary NameDELFLEX Neutral pH
Generic NameDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
Dosage FormSolution
Route of AdministrationINTRAPERITONEAL
Marketing Start Date1992-08-19
Marketing CategoryNDA / NDA
Application NumberNDA020171
Labeler NameFresenius Medical Care North America
Substance NameDEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
Active Ingredient Strength4 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesOsmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49230-212-92

5 BAG in 1 CARTON (49230-212-92) > 2000 mL in 1 BAG
Marketing Start Date1992-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49230-212-30 [49230021230]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19

NDC 49230-212-61 [49230021261]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2019-05-22

NDC 49230-212-15 [49230021215]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19
Marketing End Date2015-08-13

NDC 49230-212-31 [49230021231]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2013-10-25

NDC 49230-212-92 [49230021292]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19

NDC 49230-212-95 [49230021295]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19

NDC 49230-212-93 [49230021293]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2015-08-13

NDC 49230-212-23 [49230021223]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19

NDC 49230-212-51 [49230021251]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2019-05-22

NDC 49230-212-50 [49230021250]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19

NDC 49230-212-90 [49230021290]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2015-08-13

NDC 49230-212-97 [49230021297]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2019-05-22

NDC 49230-212-98 [49230021298]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2013-10-25

NDC 49230-212-60 [49230021260]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19

NDC 49230-212-91 [49230021291]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2015-08-13

NDC 49230-212-94 [49230021294]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19

NDC 49230-212-96 [49230021296]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-19
Marketing End Date2013-10-25

NDC 49230-212-25 [49230021225]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA020171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-19
Marketing End Date2015-08-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE4.25 g/100mL

OpenFDA Data

SPL SET ID:b2dde4a1-398b-11e2-81c1-0800200c9a66
Manufacturer
UNII

Pharmacological Class

  • Osmotic Laxative [EPC]
  • Increased Large Intestinal Motility [PE]
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
  • Osmotic Activity [MoA]
  • Osmotic Laxative [EPC]
  • Increased Large Intestinal Motility [PE]
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
  • Osmotic Activity [MoA]
  • Blood Coagulation Factor [EPC]
  • Increased Coagulation Factor Activity [PE]
  • Calcium [CS]
  • Cations
  • Divalent [CS]
  • Calculi Dissolution Agent [EPC]
  • Magnesium Ion Exchange Activity [MoA]
  • Osmotic Laxative [EPC]
  • Osmotic Activity [MoA]
  • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
  • Increased Large Intestinal Motility [PE]
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]

NDC Crossover Matching brand name "DELFLEX Neutral pH" or generic name "Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate"

NDCBrand NameGeneric Name
49230-188DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-191DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-194DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-197DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-200DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-203DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-206DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-209DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate
49230-212DELFLEXDextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate

Trademark Results [DELFLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DELFLEX
DELFLEX
78560327 3054723 Live/Registered
Fresenius Medical Care Holdings, Inc.
2005-02-03
DELFLEX
DELFLEX
74094930 1687522 Dead/Cancelled
Delmed Inc.
1990-09-06
DELFLEX
DELFLEX
72352463 0922661 Dead/Expired
DELTA STRAPPING INDUSTRIES, INC.
1970-02-26

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