dianeal pd-2 with dextrose

Generic: sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

Labeler: vantive us healthcare llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dianeal pd-2 with dextrose
Generic Name sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Labeler vantive us healthcare llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAPERITONEAL
Active Ingredients

calcium chloride 25.7 mg/100mL, dextrose monohydrate 1.5 g/100mL, magnesium chloride 5.08 mg/100mL, sodium chloride 538 mg/100mL, sodium lactate 448 mg/100mL

Manufacturer
Vantive US Healthcare LLC

Identifiers & Regulatory

Product NDC 0941-0411
Product ID 0941-0411_1fe7ab39-a56f-48bb-97fe-71eb295870a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017512
Listing Expiration 2027-12-31
Marketing Start 1978-09-27

Pharmacologic Class

Classes
blood coagulation factor [epc] calcium [cs] calculi dissolution agent [epc] cations divalent [cs] increased coagulation factor activity [pe] 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] phosphate binder [epc] phosphate chelating activity [moa] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09410411
Hyphenated Format 0941-0411

Supplemental Identifiers

RxCUI
799999 800003 800057 800061 800062 800064 800066 800074 800111 800115 800472 800474
UNII
M4I0D6VV5M TU7HW0W0QT 451W47IQ8X 02F3473H9O LX22YL083G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dianeal pd-2 with dextrose (source: ndc)
Generic Name sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose (source: ndc)
Application Number NDA017512 (source: ndc)
Routes
INTRAPERITONEAL
source: ndc

Resolved Composition

Strengths
  • 25.7 mg/100mL
  • 1.5 g/100mL
  • 5.08 mg/100mL
  • 538 mg/100mL
  • 448 mg/100mL
source: ndc
Packaging
  • 3000 mL in 1 BAG (0941-0411-04)
  • 1000 mL in 1 BAG (0941-0411-05)
  • 2000 mL in 1 BAG (0941-0411-06)
  • 5000 mL in 1 BAG (0941-0411-07)
  • 6000 mL in 1 BAG (0941-0411-11)
source: ndc

Packages (5)

0941-0411-04 3000 mL in 1 BAG (0941-0411-04) 0941-0411-05 1000 mL in 1 BAG (0941-0411-05) 0941-0411-06 2000 mL in 1 BAG (0941-0411-06) 0941-0411-07 5000 mL in 1 BAG (0941-0411-07) 0941-0411-11 6000 mL in 1 BAG (0941-0411-11)

Ingredients (5)

calcium chloride (25.7 mg/100mL) dextrose monohydrate (1.5 g/100mL) magnesium chloride (5.08 mg/100mL) sodium chloride (538 mg/100mL) sodium lactate (448 mg/100mL)

Linked Drug Pages (1)

DIANEAL Low Calcium with Dextrose, DIANEAL PD-2 with Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAPERITONEAL"], "spl_id": "1fe7ab39-a56f-48bb-97fe-71eb295870a6", "openfda": {"unii": ["M4I0D6VV5M", "TU7HW0W0QT", "451W47IQ8X", "02F3473H9O", "LX22YL083G"], "rxcui": ["799999", "800003", "800057", "800061", "800062", "800064", "800066", "800074", "800111", "800115", "800472", "800474"], "spl_set_id": ["aa268d3f-7389-4f25-801f-5d4825495f08"], "manufacturer_name": ["Vantive US Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3000 mL in 1 BAG (0941-0411-04)", "package_ndc": "0941-0411-04", "marketing_start_date": "19780927"}, {"sample": false, "description": "1000 mL in 1 BAG (0941-0411-05)", "package_ndc": "0941-0411-05", "marketing_start_date": "19780927"}, {"sample": false, "description": "2000 mL in 1 BAG (0941-0411-06)", "package_ndc": "0941-0411-06", "marketing_start_date": "19780927"}, {"sample": false, "description": "5000 mL in 1 BAG (0941-0411-07)", "package_ndc": "0941-0411-07", "marketing_start_date": "19780927"}, {"sample": false, "description": "6000 mL in 1 BAG (0941-0411-11)", "package_ndc": "0941-0411-11", "marketing_start_date": "19780927"}], "brand_name": "DIANEAL PD-2 with Dextrose", "product_id": "0941-0411_1fe7ab39-a56f-48bb-97fe-71eb295870a6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "0941-0411", "generic_name": "sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose", "labeler_name": "Vantive US Healthcare LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIANEAL PD-2 with Dextrose", "active_ingredients": [{"name": "CALCIUM CHLORIDE", "strength": "25.7 mg/100mL"}, {"name": "DEXTROSE MONOHYDRATE", "strength": "1.5 g/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "5.08 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "538 mg/100mL"}, {"name": "SODIUM LACTATE", "strength": "448 mg/100mL"}], "application_number": "NDA017512", "marketing_category": "NDA", "marketing_start_date": "19780927", "listing_expiration_date": "20271231"}