NDC 0338-0355

Osmitrol

Mannitol

Osmitrol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Mannitol.

• Product ID: 0338-0355_3cfaf124-d869-447e-ab29-a09e95321d44
• NDC: 0338-0355
• Product Type: Human Prescription Drug
• Proprietary Name: Osmitrol
• Generic Name: Mannitol
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1964-06-08
• Marketing Category: NDA / NDA
• Application Number: NDA013684
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: MANNITOL
• Active Ingredient Strength: 15 g/100mL
• Pharm Classes: Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0338-0355-03

500 mL in 1 BAG (0338-0355-03)

• Marketing Start Date: 1964-06-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-0355-03 [00338035503]

Osmitrol INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA013684
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1964-06-08

Drug Details

Active Ingredients

Ingredient	Strength
MANNITOL	15 g/100mL

OpenFDA Data

• SPL SET ID: 0d914965-7001-45cb-ba51-d7c5964b05bc
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • 3OWL53L36A
• RxNorm Concept Unique ID - RxCUI:
  • 1791409
  • 1791408
  • 1791395
  • 1791403
  • 1791404
  • 311448
  • 206536
  • 206537
  • 206535
  • 311452

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0338-0351	Osmitrol	Mannitol
0338-0353	Osmitrol	Mannitol
0338-0355	Osmitrol	Mannitol
0338-0357	Osmitrol	Mannitol
67850-552	Aridol Bronchial Challenge Test Kit	mannitol
10122-212	Bronchitol	mannitol
62171-100	GD11 Rx SCM C5	MANNITOL
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