Osmitrol

Product NDC
0338-0355
11-digit product format
003380355
Labeler code
0338
Product ID
0338-0355_baad4f65-0756-4e75-983b-7a58ba0b9add
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mannitol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA013684
Marketing category
NDA
Marketing start
1964-06-08
Marketing end
0000-00-00
Substance
MANNITOL
Active strength
15 g/100mL
Pharmacologic classes
Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0355-03ML - Milliliter0338-0355265630f0-de68-4eb8-8615-4cfc26a89eb812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0355OSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]14Legacy NDC20250519_0d914965-7001-45cb-ba51-d7c5964b05bc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0355-0300338035503500 mL in 1 BAG (0338-0355-03) 500 ml1964-06-080000-00-00NoNoCurrent