FDA.reportPublic FDA data

DIANEAL PD-2 with Dextrose

Product NDC
0941-0427
11-digit product format
009410427
Labeler code
0941
Product ID
0941-0427_194f41a6-655b-456a-955f-7566eb429b7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAPERITONEAL
Labeler
Vantive US Healthcare LLC
Application
NDA020163
Marketing category
NDA
Marketing start
1992-12-04
Substance
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength
25.7; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIANEAL PD-2 with Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CHLORIDE25.7 mg/100mL
DEXTROSE MONOHYDRATE2.5 g/100mL
MAGNESIUM CHLORIDE5.08 mg/100mL
SODIUM CHLORIDE538 mg/100mL
SODIUM LACTATE448 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X, LX22YL083G, M4I0D6VV5M, 02F3473H9O, TU7HW0W0QT
Rxcui799999, 800003, 800057, 800061, 800062, 800064, 800066, 800074, 800111, 800115, 800472, 800474

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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95250459-30e4-45c1-b08a-993044f49109Product name220250805
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0941-0427-52DIANEAL PD-2 with Dextrose2000 mL in 1 BAGINJECTION, SOLUTION200037
0941-0427-53DIANEAL PD-2 with Dextrose2500 mL in 1 BAGINJECTION, SOLUTION250037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0941-0427-52ML - Milliliter0941-04276dd6ebf0-029c-47ea-90df-d57f4ec26c5612013-02-13
0941-0427-53ML - Milliliter0941-04271c5c8074-5f33-4769-ae1d-c4b9493a50fe12013-02-13
0941-0427-55ML - Milliliter0941-04277b683c5e-a463-48cc-9885-ae37085a427d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CHLORIDEACTIVE INGREDIENTM4I0D6VV5MDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
MAGNESIUM CHLORIDEACTIVE INGREDIENT02F3473H9ODIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
SODIUM LACTATEACTIVE INGREDIENTTU7HW0W0QTDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
CHLORIDE IONACTIVE MOIETYQ32ZN48698DIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
LACTIC ACIDACTIVE MOIETY33X04XA5ATDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
SODIUM CATIONACTIVE MOIETYLYR4M0NH37DIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14
WATERINACTIVE INGREDIENT059QF0KO0RDIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0941-0427DIANEAL PD-2 WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]34Current NDC, Legacy NDC, 2 package rows20250425_aa268d3f-7389-4f25-801f-5d4825495f08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
800064Dianeal PD-2/2.5 Intraperitoneal SolutionPSNaa268d3f-7389-4f25-801f-5d4825495f0837
800061calcium chloride 0.00014 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/1.5]SBDaa268d3f-7389-4f25-801f-5d4825495f0837
800064calcium chloride 0.00014 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/2.5]SBDaa268d3f-7389-4f25-801f-5d4825495f0837
800003calcium chloride 0.00014 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/4.25]SBDaa268d3f-7389-4f25-801f-5d4825495f0837
800474calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5]SBDaa268d3f-7389-4f25-801f-5d4825495f0837
800115calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5]SBDaa268d3f-7389-4f25-801f-5d4825495f0837
800074calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25]SBDaa268d3f-7389-4f25-801f-5d4825495f0837
800057calcium chloride 0.00014 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCDaa268d3f-7389-4f25-801f-5d4825495f0837
800062calcium chloride 0.00014 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCDaa268d3f-7389-4f25-801f-5d4825495f0837
799999calcium chloride 0.00014 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCDaa268d3f-7389-4f25-801f-5d4825495f0837
800472calcium chloride 0.000996 MEQ/ML / glucose 0.6 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCDaa268d3f-7389-4f25-801f-5d4825495f0837
800111calcium chloride 0.000996 MEQ/ML / glucose 1 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCDaa268d3f-7389-4f25-801f-5d4825495f0837
800066calcium chloride 0.000996 MEQ/ML / glucose 1.7 MG/ML / magnesium chloride 0.0000245 MEQ/ML / sodium chloride 0.00368 MEQ/ML / sodium lactate 0.0016 MEQ/ML Intraperitoneal SolutionSCDaa268d3f-7389-4f25-801f-5d4825495f0837
800057Calcium Chloride 0.00014 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800061Calcium Chloride 0.00014 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/1.5]SYaa268d3f-7389-4f25-801f-5d4825495f0837
800062Calcium Chloride 0.00014 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800064Calcium Chloride 0.00014 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/2.5]SYaa268d3f-7389-4f25-801f-5d4825495f0837
799999Calcium Chloride 0.00014 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800003Calcium Chloride 0.00014 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal PD-2/4.25]SYaa268d3f-7389-4f25-801f-5d4825495f0837
800472Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800474Calcium Chloride 0.000996 MEQ/ML / Glucose 0.6 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 1.5]SYaa268d3f-7389-4f25-801f-5d4825495f0837
800111Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800115Calcium Chloride 0.000996 MEQ/ML / Glucose 1 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 2.5]SYaa268d3f-7389-4f25-801f-5d4825495f0837
800066Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800074Calcium Chloride 0.000996 MEQ/ML / Glucose 1.7 MG/ML / Magnesium Chloride 0.0000245 MEQ/ML / NaCl 0.00368 MEQ/ML / Sodium Lactate 0.0016 MEQ/ML Intraperitoneal Solution [Dianeal Low Calcium 4.25]SYaa268d3f-7389-4f25-801f-5d4825495f0837
800474Dianeal Low Calcium 1.5 % Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800115Dianeal Low Calcium 2.5 % Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800074Dianeal Low Calcium 4.25 % Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800061Dianeal PD-2/1.5 2500 ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800064Dianeal PD-2/2.5 2500 ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837
800003Dianeal PD-2/4.25 2500 ML Intraperitoneal SolutionSYaa268d3f-7389-4f25-801f-5d4825495f0837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0941-0427-52009410427522000 mL in 1 BAG (0941-0427-52) 2000 ml1992-12-040000-00-00NoNoCurrent
0941-0427-53009410427532500 mL in 1 BAG (0941-0427-53) 2500 ml1992-12-040000-00-00NoNoCurrent
0941-0427-55009410427553000 mL in 1 BAG (0941-0427-55) 3000 ml1992-12-040000-00-00NoNoCurrent