NDC 63323-024

Mannitol

Mannitol

Mannitol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Mannitol.

• Product ID: 63323-024_9491f22f-5d6b-77d9-e053-2995a90a9a1e
• NDC: 63323-024
• Product Type: Human Prescription Drug
• Proprietary Name: Mannitol
• Generic Name: Mannitol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2000-03-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA080677
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: MANNITOL
• Active Ingredient Strength: 250 mg/mL
• Pharm Classes: Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-024-25

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) > 50 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2000-03-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-024-29 [63323002429]

Mannitol INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA080677
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-03-19
• Marketing End Date: 2015-09-30

NDC 63323-024-25 [63323002425]

Mannitol INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA080677
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2000-03-19

NDC 63323-024-05 [63323002405]

Mannitol INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA080677
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2000-03-19
• Marketing End Date: 2012-11-19

Drug Details

Active Ingredients

Ingredient	Strength
MANNITOL	250 mg/mL

OpenFDA Data

• SPL SET ID: c395e13d-6ea1-4104-8b37-669cfb982f04
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 3OWL53L36A
• RxNorm Concept Unique ID - RxCUI:
  • 311450
• UPC Code:
  • 0363323024253

Pharmacological Class

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

NDC Crossover Matching brand name "Mannitol" or generic name "Mannitol"

NDC	Brand Name	Generic Name
0264-2303	Mannitol	Mannitol
0264-7578	Mannitol	MANNITOL
0404-9905	Mannitol	Mannitol
0409-4031	Mannitol	MANNITOL
0409-7715	Mannitol	MANNITOL
0990-7715	Mannitol	MANNITOL
51662-1468	MANNITOL	MANNITOL
52584-031	Mannitol	Mannitol
63323-024	Mannitol	MANNITOL
67850-552	Aridol Bronchial Challenge Test Kit	mannitol
10122-212	Bronchitol	mannitol
62171-100	GD11 Rx SCM C5	MANNITOL
0338-0351	Osmitrol	Mannitol
0338-0353	Osmitrol	Mannitol
0338-0355	Osmitrol	Mannitol
0338-0357	Osmitrol	Mannitol