NDC 49230-191

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 ID49230-191_369a88c0-add6-11e2-9e96-0800200c9a66
NDC49230-191
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 Date1984-11-30
Marketing CategoryNDA / NDA
Application NumberNDA018883
Labeler NameFresenius Medical Care North America
Substance NameDEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
Active Ingredient Strength3 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 49230-191-50

2 BAG in 1 CARTON (49230-191-50) > 5000 mL in 1 BAG
Marketing Start Date1984-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49230-191-20 [49230019120]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-11-30
Marketing End Date2015-08-13

NDC 49230-191-25 [49230019125]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-08-13

NDC 49230-191-30 [49230019130]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-08-13

NDC 49230-191-61 [49230019161]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2019-05-22

NDC 49230-191-92 [49230019192]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-03-25

NDC 49230-191-50 [49230019150]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-11-30

NDC 49230-191-51 [49230019151]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2019-05-22

NDC 49230-191-94 [49230019194]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-03-25

NDC 49230-191-31 [49230019131]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2013-10-25

NDC 49230-191-60 [49230019160]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30

NDC 49230-191-93 [49230019193]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-03-25

NDC 49230-191-91 [49230019191]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-03-25

NDC 49230-191-96 [49230019196]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2013-10-25

NDC 49230-191-10 [49230019110]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-08-13

NDC 49230-191-98 [49230019198]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2013-10-25

NDC 49230-191-97 [49230019197]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2019-05-22

NDC 49230-191-23 [49230019123]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-08-13

NDC 49230-191-90 [49230019190]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-03-25

NDC 49230-191-95 [49230019195]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-03-25

NDC 49230-191-15 [49230019115]

DELFLEX SOLUTION
Marketing CategoryNDA
Application NumberNDA018883
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1984-11-30
Marketing End Date2015-08-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE2.5 g/100mL

OpenFDA Data

SPL SET ID:515dcee0-3e34-11e2-a25f-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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