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DIANEAL PD-2 with Dextrose

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose · Injection, Solution

Prescription NDA TE AT RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
DIANEAL PD-2 with Dextrose
Generic name
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
Dosage form
Injection, Solution
Route
Intraperitoneal
Marketing category
NDA · NDA
Labeler
Vantive US Healthcare LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
7
NDC product codes
7
Packages
22
Data completeness
61% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Calcium Chloride 25.7 mg/100mL 828525 View
Dextrose Monohydrate 1.5 g/100mL 799999 View
Dextrose Monohydrate 2.5 g/100mL 799999 View
Dextrose Monohydrate 4.25 g/100mL 799999 View
Magnesium Chloride 5.08 mg/100mL 799999 View
Sodium Chloride 538 mg/100mL 707251 View
Sodium Lactate 448 mg/100mL 799999 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Intraperitoneal
Presentations
29

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Blood Coagulation Factor [EPC] EPC All 23 members
Calcium [CS] CS All 23 members
Calculi Dissolution Agent [EPC] EPC All 33 members
Cations EPC All 23 members
Divalent [CS] CS All 23 members
Increased Coagulation Factor Activity [PE] PE All 23 members
Increased Large Intestinal Motility [PE] PE All 83 members
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] PE All 83 members
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] PE All 30 members
Magnesium Ion Exchange Activity [MoA] MoA All 30 members
Osmotic Activity [MoA] MoA All 105 members
Osmotic Laxative [EPC] EPC All 103 members
Phosphate Binder [EPC] EPC All 42 members
Phosphate Chelating Activity [MoA] MoA All 42 members
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] PE All 53 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020163
Application type
NDA · New Drug Application
Approval date
December 4, 1992
Sponsor
VANTIVE US HLTHCARE
Products on application
3
Submissions recorded
19
Products approved under application 020163.
Product Trade name Form Strength Ingredient Status TE Flags
020163-001 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER SOLUTION CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Prescription AT RLD
020163-002 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER SOLUTION CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Prescription AT RLD
020163-003 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER SOLUTION CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Prescription AT RLD

Therapeutic equivalence

Source: Orange Book
TE code
AT
Reference Listed Drug
Yes
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020163.
Type No. Action Status Date Review
Supplement 30 Labeling Approved June 5, 2023 Standard
Supplement 28 Labeling Approved August 16, 2016 Standard
Supplement 27 Labeling Approved September 1, 2015 Standard
Supplement 26 Manufacturing (CMC) Approved June 5, 2015 Standard
Supplement 25 Labeling Approved February 9, 2015 Standard
Supplement 24 Manufacturing (CMC) Approved September 30, 2014 Standard
Supplement 23 Manufacturing (CMC) Approved April 26, 2013 Standard
Supplement 20 Labeling Approved April 19, 2013 Standard
Supplement 13 Manufacturing (CMC) Approved August 9, 2005 Standard
Supplement 12 Labeling Approved August 9, 2005 Standard
Supplement 8 Manufacturing (CMC) Approved February 12, 2002 Standard
Supplement 7 Manufacturing (CMC) Approved August 22, 2001 Standard
Supplement 6 Manufacturing (CMC) Approved April 29, 1997 Standard
Supplement 5 Manufacturing (CMC) Approved November 22, 1996 Standard
Supplement 4 Manufacturing (CMC) Approved February 9, 1995 Standard
Supplement 1 Manufacturing (CMC) Approved September 30, 1994 Standard
Supplement 3 Manufacturing (CMC) Approved June 1, 1994 Standard
Supplement 2 Manufacturing (CMC) Approved February 18, 1994 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved December 4, 1992 Standard

Review documents

  • 0 · Supplement · June 6, 2023
  • 0 · Supplement · June 6, 2023
  • 0 · Supplement · August 17, 2016
  • 0 · Supplement · August 16, 2016
  • 0 · Supplement · September 4, 2015
  • 0 · Supplement · September 4, 2015
  • 0 · Supplement · February 10, 2015
  • 0 · Supplement · February 10, 2015
  • 0 · Supplement · April 24, 2013
  • 0 · Supplement · April 23, 2013
  • 0 · Supplement · August 11, 2005
  • 0 · Supplement · August 11, 2005

Adverse event reports

Source: openFDA FAERS
271,787
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SODIUM CHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Shortages

Source: FDA Drug Shortages
Availability records from the FDA Drug Shortages database.
Status Availability Company Presentation Updated
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0426-53) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0429-53) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0415-06) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0429-52) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0411-07) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0413-06) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0413-07) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0426-52) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0415-07) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 1.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0411-06) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0427-52) August 3, 2026
To Be Discontinued Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, Intraperitoneal Injection, Solution, 25.7 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 0941-0427-53) August 3, 2026

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0941-0411-04 0941-0411 Vantive US Healthcare LLC 3000 mL in 1 BAG (0941-0411-04) September 27, 1978
0941-0411-05 0941-0411 Vantive US Healthcare LLC 1000 mL in 1 BAG (0941-0411-05) September 27, 1978
0941-0411-06 0941-0411 Vantive US Healthcare LLC 2000 mL in 1 BAG (0941-0411-06) September 27, 1978
0941-0411-07 0941-0411 Vantive US Healthcare LLC 5000 mL in 1 BAG (0941-0411-07) September 27, 1978
0941-0411-11 0941-0411 Vantive US Healthcare LLC 6000 mL in 1 BAG (0941-0411-11) September 27, 1978
0941-0413-01 0941-0413 Vantive US Healthcare LLC 6000 mL in 1 BAG (0941-0413-01) September 27, 1978
0941-0413-04 0941-0413 Vantive US Healthcare LLC 3000 mL in 1 BAG (0941-0413-04) September 27, 1978
0941-0413-05 0941-0413 Vantive US Healthcare LLC 1000 mL in 1 BAG (0941-0413-05) September 27, 1978
0941-0413-06 0941-0413 Vantive US Healthcare LLC 2000 mL in 1 BAG (0941-0413-06) September 27, 1978
0941-0413-07 0941-0413 Vantive US Healthcare LLC 5000 mL in 1 BAG (0941-0413-07) September 27, 1978
0941-0415-01 0941-0415 Vantive US Healthcare LLC 6000 mL in 1 BAG (0941-0415-01) September 27, 1978
0941-0415-04 0941-0415 Vantive US Healthcare LLC 3000 mL in 1 BAG (0941-0415-04) September 27, 1978
0941-0415-05 0941-0415 Vantive US Healthcare LLC 1000 mL in 1 BAG (0941-0415-05) September 28, 1978
0941-0415-06 0941-0415 Vantive US Healthcare LLC 2000 mL in 1 BAG (0941-0415-06) September 27, 1978
0941-0415-07 0941-0415 Vantive US Healthcare LLC 5000 mL in 1 BAG (0941-0415-07) September 27, 1978
0941-0426-52 0941-0426 Vantive US Healthcare LLC 2000 mL in 1 BAG (0941-0426-52) December 4, 1992
0941-0426-53 0941-0426 Vantive US Healthcare LLC 2500 mL in 1 BAG (0941-0426-53) December 4, 1992
0941-0427-52 0941-0427 Vantive US Healthcare LLC 2000 mL in 1 BAG (0941-0427-52) December 4, 1992
0941-0427-53 0941-0427 Vantive US Healthcare LLC 2500 mL in 1 BAG (0941-0427-53) December 4, 1992
0941-0429-52 0941-0429 Vantive US Healthcare LLC 2000 mL in 1 BAG (0941-0429-52) December 4, 1992
0941-0429-53 0941-0429 Vantive US Healthcare LLC 2500 mL in 1 BAG (0941-0429-53) December 4, 1992
0941-0698-06 0941-0698 Vantive US Healthcare LLC 6 BAG in 1 CARTON (0941-0698-06) / 2000 mL in 1 BAG (0941-0698-01) October 30, 2024
0941-0411 0941-0411 Vantive US Healthcare LLC — September 27, 1978
0941-0413 0941-0413 Vantive US Healthcare LLC — September 27, 1978
0941-0415 0941-0415 Vantive US Healthcare LLC — September 27, 1978
0941-0426 0941-0426 Vantive US Healthcare LLC — December 4, 1992
0941-0427 0941-0427 Vantive US Healthcare LLC — December 4, 1992
0941-0429 0941-0429 Vantive US Healthcare LLC — December 4, 1992
0941-0698 0941-0698 Vantive US Healthcare LLC — October 30, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Drug Shortages FDA Supply availability

Generated September 25, 2026 · 11 sections on this page.