NDC 0942-9602

InterSol

Platelet Additive 3

InterSol is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Fenwal, Inc.. The primary component is Sodium Chloride; Sodium Acetate; Trisodium Citrate Dihydrate; Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic, Monohydrate.

• Product ID: 0942-9602_77e5b3e8-957f-4c2b-b528-e3b18b2cc70e
• NDC: 0942-9602
• Product Type: Human Prescription Drug
• Proprietary Name: InterSol
• Generic Name: Platelet Additive 3
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-06-05
• Marketing Category: NDA / NDA
• Application Number: BN080041
• Labeler Name: Fenwal, Inc.
• Substance Name: SODIUM CHLORIDE; SODIUM ACETATE; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
• Active Ingredient Strength: 452 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0942-9602-12

500 mL in 1 BAG (0942-9602-12)

• Marketing Start Date: 2019-06-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0942-9602-12 [00942960212]

InterSol SOLUTION

• Marketing Category: NDA
• Application Number: BN080041
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-05

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	452 mg/100mL

OpenFDA Data

• SPL SET ID: a00c4a93-cde2-4753-81f7-0d6fee9fb690
• Manufacturer:
  • Fenwal, Inc.
• UNII:
  • 593YOG76RN
  • GR686LBA74
  • 4550K0SC9B
  • 451W47IQ8X
  • B22547B95K

Pharmacological Class

• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]

NDC Crossover Matching brand name "InterSol" or generic name "Platelet Additive 3"

NDC	Brand Name	Generic Name
0942-9601	InterSol	Platelet Additive 3
0942-9602	InterSol	Platelet Additive 3