NDC 0409-7981

Sorbitol-Mannitol

Sorbitol And Mannitol

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

• Product ID: 0409-7981_21ea390d-ede6-449c-a4e6-e2756f6ca2ee
• NDC: 0409-7981
• Product Type: Human Prescription Drug
• Proprietary Name: Sorbitol-Mannitol
• Generic Name: Sorbitol And Mannitol
• Dosage Form: Irrigant
• Route of Administration: URETHRAL
• Marketing Start Date: 2005-05-24
• Marketing Category: NDA / NDA
• Application Number: NDA018316
• Labeler Name: Hospira, Inc.
• Substance Name: SORBITOL; MANNITOL
• Active Ingredient Strength: 3 g/100mL; g/100mL
• Pharm Classes: Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0409-7981-08

4 POUCH in 1 CASE (0409-7981-08) > 1 BAG in 1 POUCH > 3000 mL in 1 BAG

• Marketing Start Date: 2005-05-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-7981-08 [00409798108]

Sorbitol-Mannitol IRRIGANT

• Marketing Category: NDA
• Application Number: NDA018316
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-05-24
• Marketing End Date: 2020-11-01

Drug Details

Active Ingredients

Ingredient	Strength
SORBITOL	2.7 g/100mL

OpenFDA Data

• SPL SET ID: 672d4453-9dd5-4577-a38f-c15b7f33e9fb
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 506T60A25R
  • 3OWL53L36A
• RxNorm Concept Unique ID - RxCUI:
  • 311446

Pharmacological Class

• 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