Mannitol

Product NDC
0990-7715
11-digit product format
009907715
Labeler code
0990
Product ID
0990-7715_b0dfadd1-70b5-49f5-8b63-60d3b4e1cbf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MANNITOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA019603
Marketing category
NDA
Marketing start
2019-05-31
Substance
MANNITOL
Active strength
20 g/100mL
Pharmacologic classes
Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mannitol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MANNITOL20 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3OWL53L36A
Rxcui1791403, 1791408

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7715-02Mannitol24 in 1 CASEINJECTION, SOLUTION245
0990-7715-02Mannitol1 in 1 POUCHINJECTION, SOLUTION15
0990-7715-03Mannitol12 in 1 CASEINJECTION, SOLUTION125
0990-7715-03Mannitol1 in 1 POUCHINJECTION, SOLUTION15
0990-7715-12Mannitol250 mL in 1 BAGINJECTION, SOLUTION2505
0990-7715-13Mannitol500 mL in 1 BAGINJECTION, SOLUTION5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7715-03ML - Milliliter0990-7715f898ab0f-90a1-4d72-8c81-93021b05aa7f12020-01-03
0990-7715-13ML - Milliliter0990-77155f29eccf-1abd-4b29-ad95-9312f38b466d12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7715MANNITOL INJECTION, SOLUTION [ICU MEDICAL INC.]4Current NDC, Legacy NDC, 6 package rows20221208_ba7bf864-8a4d-4262-8fd1-00174fa2f9d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791403mannitol 20 % in 250 ML InjectionPSNba7bf864-8a4d-4262-8fd1-00174fa2f9d15
1791408mannitol 20 % in 500 ML InjectionPSNba7bf864-8a4d-4262-8fd1-00174fa2f9d15
1791403250 ML mannitol 200 MG/ML InjectionSCDba7bf864-8a4d-4262-8fd1-00174fa2f9d15
1791408500 ML mannitol 200 MG/ML InjectionSCDba7bf864-8a4d-4262-8fd1-00174fa2f9d15
1791403mannitol 20 % per 250 ML InjectionSYba7bf864-8a4d-4262-8fd1-00174fa2f9d15
1791408mannitol 20 % per 500 ML InjectionSYba7bf864-8a4d-4262-8fd1-00174fa2f9d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7715-020099077150224 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12) 24 pouch2019-08-010000-00-00NoNoCurrent
0990-7715-030099077150312 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13) 12 pouch2019-05-310000-00-00NoNoCurrent
0990-7715-1200990771512250 mL in 1 BAG250 mlHistorical
0990-7715-1300990771513500 mL in 1 BAG500 mlHistorical