NDC 0990-7981

Sorbitol-Mannitol

Sorbitol And Mannitol

Sorbitol-Mannitol is a Urethral Irrigant in the Human Prescription Drug category. It is labeled and distributed by Icu Medical Inc.. The primary component is Mannitol; Sorbitol.

• Product ID: 0990-7981_750091b2-344c-461a-9f6a-0737e53041b2
• NDC: 0990-7981
• Product Type: Human Prescription Drug
• Proprietary Name: Sorbitol-Mannitol
• Generic Name: Sorbitol And Mannitol
• Dosage Form: Irrigant
• Route of Administration: URETHRAL
• Marketing Start Date: 2019-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA018316
• Labeler Name: ICU Medical Inc.
• Substance Name: MANNITOL; SORBITOL
• Active Ingredient Strength: 1 g/100mL; g/100mL
• Pharm Classes: Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0990-7981-08

4 POUCH in 1 CASE (0990-7981-08) > 1 BAG in 1 POUCH > 3000 mL in 1 BAG

• Marketing Start Date: 2019-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0990-7981-08 [00990798108]

Sorbitol-Mannitol IRRIGANT

• Marketing Category: NDA
• Application Number: NDA018316
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-10-01

Drug Details

Active Ingredients

Ingredient	Strength
SORBITOL	2.7 g/100mL

OpenFDA Data

• SPL SET ID: 5b44e248-4b7b-4777-954a-921c7b309944
• Manufacturer:
  • ICU Medical Inc.
• UNII:
  • 506T60A25R
  • 3OWL53L36A
• RxNorm Concept Unique ID - RxCUI:
  • 311446

Pharmacological Class

• Increased Diuresis [PE]
• Osmotic Activity [MoA]
• Osmotic Diuretic [EPC]
• Increased Diuresis [PE]
• Osmotic Activity [MoA]
• Osmotic Diuretic [EPC]

NDC Crossover Matching brand name "Sorbitol-Mannitol" or generic name "Sorbitol And Mannitol"

NDC	Brand Name	Generic Name
0409-7981	Sorbitol-Mannitol	SORBITOL and MANNITOL
0990-7981	Sorbitol-Mannitol	SORBITOL and MANNITOL