NDC 0941-0415

DIANEAL PD-2 with Dextrose

Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose

DIANEAL PD-2 with Dextrose is a Intraperitoneal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Calcium Chloride; Dextrose Monohydrate; Magnesium Chloride; Sodium Chloride; Sodium Lactate.

• Product ID: 0941-0415_1bac9069-af32-4e88-9d96-bf4006f0729f
• NDC: 0941-0415
• Product Type: Human Prescription Drug
• Proprietary Name: DIANEAL PD-2 with Dextrose
• Generic Name: Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose
• Dosage Form: Injection, Solution
• Route of Administration: INTRAPERITONEAL
• Marketing Start Date: 1978-09-27
• Marketing Category: NDA / NDA
• Application Number: NDA017512
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
• Active Ingredient Strength: 26 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm 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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0941-0415-01

6000 mL in 1 BAG (0941-0415-01)

• Marketing Start Date: 1978-09-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0941-0415-48 [00941041548]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2009-02-28

NDC 0941-0415-40 [00941041540]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2001-09-30

NDC 0941-0415-07 [00941041507]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27

NDC 0941-0415-01 [00941041501]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27

NDC 0941-0415-41 [00941041541]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2010-04-30

NDC 0941-0415-49 [00941041549]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2011-10-31

NDC 0941-0415-08 [00941041508]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2015-02-18

NDC 0941-0415-47 [00941041547]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2012-06-30

NDC 0941-0415-06 [00941041506]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27

NDC 0941-0415-28 [00941041528]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2012-11-30

NDC 0941-0415-42 [00941041542]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2003-01-31

NDC 0941-0415-04 [00941041504]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27

NDC 0941-0415-25 [00941041525]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2012-02-29

NDC 0941-0415-05 [00941041505]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-28

NDC 0941-0415-44 [00941041544]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2002-09-30

NDC 0941-0415-45 [00941041545]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2002-08-31

NDC 0941-0415-43 [00941041543]

DIANEAL PD-2 with Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-09-27
• Marketing End Date: 2011-12-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROSE MONOHYDRATE	4.25 g/100mL

OpenFDA Data

• SPL SET ID: aa268d3f-7389-4f25-801f-5d4825495f08
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • TU7HW0W0QT
  • M4I0D6VV5M
  • 02F3473H9O
  • 451W47IQ8X
  • LX22YL083G
• RxNorm Concept Unique ID - RxCUI:
  • 800472
  • 800057
  • 800064
  • 800066
  • 800061
  • 800062
  • 800074
  • 799999
  • 800111
  • 800474
  • 800003
  • 800115

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 "DIANEAL PD-2 with Dextrose" or generic name "Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose"

NDC	Brand Name	Generic Name
0941-0411	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
0941-0413	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
0941-0415	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
0941-0429	DIANEAL PD-2 with Dextrose	DIANEAL PD-2 with Dextrose
0941-0427	DIANEAL PD-2 with Dextrose	DIANEAL PD-2 with Dextrose
0941-0426	DIANEAL PD-2 with Dextrose	DIANEAL PD-2 with Dextrose
0941-0409	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
0941-0424	DIANEAL Low Calcium with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose