FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
55154-8184
11-digit product format
551548184
Labeler code
55154
Product ID
55154-8184_2a52653d-c5c6-4578-a6d5-1c439f32af49
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA203928
Marketing category
ANDA
Marketing start
2019-04-15
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polyethylene Glycol 3350
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-8184-5Polyethylene Glycol 33507 in 1 BAGPOWDER, FOR SOLUTION75
55154-8184-5Polyethylene Glycol 335017 g in 1 POUCHPOWDER, FOR SOLUTION175

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8184POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20240119_4d524ace-9de5-4f62-9263-7cd88a36b67c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN4d524ace-9de5-4f62-9263-7cd88a36b67c5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD4d524ace-9de5-4f62-9263-7cd88a36b67c5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY4d524ace-9de5-4f62-9263-7cd88a36b67c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8184-5551548184057 POUCH in 1 BAG (55154-8184-5) / 17 g in 1 POUCH7 pouch2019-04-150000-00-00NoNoCurrent